3M™ Tegaderm™ 90647Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00707387776824), received between May 14, 2019 and May 14, 2019 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED A PATIENT WITH MULTIPLE COMORBIDITIES WAS ADMITTED WITH AN EXISTING SACRAL PRESSURE WOUND INJURY. THE NURSE REPORTED NON-3M DRESSINGS WERE INITIALLY APPLIED TO THE WOUND. ON AN UNSPECIFIED /UNKNOWN DATE, 90647 TEGADERM¿ SILICONE FOAM BORDER DRESSING(S) WERE REPORTEDLY APPLIED TO THE WOUND BY THE STAFF FOR PROTECTION FROM THE PATIENT'S DIARRHEA. THE DRESSING REPORTEDLY STAYED INTACT AND THE PATIENT'S DIARRHEA DID NOT LEAK INTO THE EXISTING WOUND. THE NURSE DID NOT HAVE SPECIFIC INFORMATION RELATED TO DATES OF DRESSING APPLICATION. THE PATIENT ALLEGEDLY EXPERIENCED MACERATION OF THE PERI-WOUND AREA FOLLOWING USE OF THE TEGADERM¿ SILICONE FOAM DRESSING. THE SKIN REPORTEDLY BECAME NECROTIC AND THE PATIENT REQUIRED TWO DEBRIDEMENT PROCEDURES. THE NURSE STATED THE USE OF THE DRESSING COULD NOT BE ATTRIBUTED TO THE WORSENING OF THE WOUND, BUT ALLEGED IT WAS A CONTRIBUTING FACTOR. THE PATIENT HAS BEEN DISCHARGED TO A LONG-TERM FACILITY, SO THE NURSE REPORTED LIMITED INFORMATION WAS AVAILABLE FOR THIS REPORT.

  Patient problems: Bacterial Infection; Necrosis

  MAUDE report 8607983 ↗