inforMED
OMDClass II

Cutaneous Tissue Adhesive With Mesh

General, Plastic Surgery · 21 CFR 878.4011

For topical application only to hold closed easily approximated skin edges of wounds such as wounds from surgical incisions, including punctures from minimally invasive surgery, and simple thorough cleansed, trauma-induced lacerations. The device may be used in conjunction with, but not in place of, deep dermal sutures.

MDR events2,139All time
Recalls0All time
Registered firms25Currently listed
510(k) clearances9All time

Recent MDR events

2,139 adverse event reports on file

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Event type breakdown

Injury1,960
Malfunction176
Unspecified2
Death1

Most-reported manufacturers

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Ethicon Inc.1,972Ethicon, Inc.74Chemence Medical Inc.14Ethicon Inc13Advanced Medical Solutions Ltd12Medline Industries Lp9Ethicon, Llc6Chemence Medical Inc5

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

25 firms currently registered for this product code

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510(k) clearances

9 clearances for this product code

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