Device, Dermal Replacement
FDA adverse event reports and recall history for device, dermal replacement (product code MDD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 186
- Deaths
- 7
- Injuries
- 112
- Malfunctions
- 62
Reports per year
Source: FDA adverse event reports by year received, 2009–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2009-03-06TerminatedPending
Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
- 2008-09-20TerminatedLabeling mix-ups
Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
- TerminatedUnder Investigation by firm
Integra Meshed Dermal Regeneration Template 5 cmx 5 cm (2 in x 2in) Rx Only Meshed Integra Dermal Regeneration Template, (Integra template) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound. Integra template is indicated for the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra template is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient Manufactured by: Integra LifeSciences Corporation 311 Enterprise Drive, Plainsboro, NJ 08536 877-444-1122 USA n 609-936-5400 outside USA 866-800-7742 fax
Integra's post QA release review of historical product release test results for Meshed IDRT products identified the Peel Strength test average result was incorrectly calculated for a single Lot (Lot 105A00324750).
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