Complications associated with Dermabond® during head and neck surgery: MAUDE and literature review

Lee, Esther; Elzomor, Amir; Zwemer, Catherine H; Chen, Alex; Thakkar, Punam

doi:10.1016/j.amjoto.2021.103330

Cited by 5 publications

(7 citation statements)

References 22 publications

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“…4 Other studies also mention underreporting or reporting bias as a concern. [5][6][7][8] In some studies, there may be a heavy skew towards reports submitted by mandatory reporters compared to voluntary reporters. 6 The "incomplete, inaccurate, or biased data" inherent to the MAUDE database limits a thorough understanding of adverse events associated with medical devices.…”

Section: Commentarymentioning

confidence: 99%

“…6 The "incomplete, inaccurate, or biased data" inherent to the MAUDE database limits a thorough understanding of adverse events associated with medical devices. 5,6 These biases may impede the generalizability of results to the national population.…”

Section: Commentarymentioning

confidence: 99%

“…10 Until these suggestions are implemented, researchers can consider supplementing MAUDE analyses with a relevant literature review to provide a more comprehensive picture. 5 Instituting a standardized reporting system of analyzed reports in MAUDE that authors conform by may also be helpful. Authors should also provide clear instructions on their search queries and search date so the audience can replicate findings.…”

Section: Commentarymentioning

confidence: 99%

“…Badger et al used the MAUDE database to evaluate device malfunction in sialendoscopy and noted underreporting as a potential drawback due to the voluntary nature of the database 4 . Other studies also mention underreporting or reporting bias as a concern 5‐8 . In some studies, there may be a heavy skew towards reports submitted by mandatory reporters compared to voluntary reporters 6 .…”

Section: Commentarymentioning

confidence: 99%

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Considerations for Use of the MAUDE Database in Otolaryngology–Head & Neck Surgery Research

Batheja,

Bentan,

Coelho

2024

Otolaryngol.--head neck surg.

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The use of the US Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) to analyze adverse events linked to medical devices has grown in recent years. MAUDE facilitates post‐market surveillance, contributing to the assessment of device performance and the identification of potential safety concerns. The database is instrumental not only for mandatory reporters such as manufacturers and healthcare facilities but also offers a platform for voluntary submissions from clinicians and patients, thus widening the scope of data collection. While the database offers valuable data, there are important limitations that must be understood in order to encourage appropriate interpretation of findings. This commentary highlights the major advantages and disadvantages of the MAUDE database, as well as describes possible areas for improvement in adverse event reporting.

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Section: Commentarymentioning

confidence: 99%

Section: Commentarymentioning

confidence: 99%

Section: Commentarymentioning

confidence: 99%

Section: Commentarymentioning

confidence: 99%

See 2 more Smart Citations

Considerations for Use of the MAUDE Database in Otolaryngology–Head & Neck Surgery Research

Batheja,

Bentan,

Coelho

2024

Otolaryngol.--head neck surg.

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show abstract

“…In Europe and Canada, n-butyl 2-cyanoacrylates in particular found their use [ 5 ] (However, this material has an extremely low fracture strength and is particularly brittle [ 2 , 5 ]. In contrast, the development of long-chain CAs (octyl-2 cyanoacrylate, Dermabond ® , Ethicon Inc., Somerville, New Jersey) proved far more successful [ 27 ]. The substance is degraded after approximately 7–10 days before histotoxic degradation can even occur.…”

Section: Categories Of Tissue Adhesivesmentioning

confidence: 99%

Tissue Adhesives in Reconstructive and Aesthetic Surgery—Application of Silk Fibroin-Based Biomaterials

Smeets

Tauer

Vollkommer

et al. 2022

IJMS

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Tissue adhesives have been successfully used in various kind of surgeries such as oral and maxillofacial surgery for some time. They serve as a substitute for suturing of tissues and shorten treatment time. Besides synthetic-based adhesives, a number of biological-based formulations are finding their way into research and clinical application. In natural adhesives, proteins play a crucial role, mediating adhesion and cohesion at the same time. Silk fibroin, as a natural biomaterial, represents an interesting alternative to conventional medical adhesives. Here, the most commonly used bioadhesives as well as the potential of silk fibroin as natural adhesives will be discussed.

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Skin repair and infection control in diabetic, obese mice using bioactive laser-activated sealants

Pallod,

Aguilera Olvera,

Ghosh

et al. 2024

Biomaterials

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Complications associated with Dermabond® during head and neck surgery: MAUDE and literature review

Cited by 5 publications

References 22 publications

Considerations for Use of the MAUDE Database in Otolaryngology–Head & Neck Surgery Research

Considerations for Use of the MAUDE Database in Otolaryngology–Head & Neck Surgery Research

Tissue Adhesives in Reconstructive and Aesthetic Surgery—Application of Silk Fibroin-Based Biomaterials

Skin repair and infection control in diabetic, obese mice using bioactive laser-activated sealants

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