3M™ Tegaderm™ 3584Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04001895928345), received between Jul 31, 2023 and Jul 31, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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. How this data works · Data updated Oct 13, 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.

• InjuryJul 31, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A 3M REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THE MOTHER OF A FEMALE PEDIATRIC CUSTOMER ALLEGED INFLAMMATION ON THE CHILD'S CHIN AFTER USE OF 3M¿ TEGADERM¿ + PAD FILM DRESSING. THE MOTHER REPORTED HER DAUGHTER SUSTAINED A CUT ON HER CHIN THAT REQUIRED A CLINICIAN CONSULTATION. THE PHYSICIAN CLEANED THE WOUND WITH NORMAL SALINE, SECURED THE SKIN INJURY WITH AN UNIDENTIFIED BRAND OF STERI-STRIPS AND APPLIED TAPE OVER IT. THE FOLLOWING DAY THE DRESSING CAME OFF AND THEY FOLLOWED UP WITH HER PRIMARY CARE PHYSICIAN. A SIMILAR DRESSING WAS RE-APPLIED; STERI-STRIPS AND TAPE. THE NEXT DAY THE MOTHER PURCHASED OVER THE COUNTER 3M¿ TEGADERM¿ +PAD FILM DRESSING FROM A LOCAL STORE. THE MOTHER PERFORMED DAILY DRESSING CHANGES. WITHIN APPROXIMATELY FOUR DAYS THE CHILD'S SKIN STARTED TO GET INFLAMED WHERE THE ADHESIVE WAS IN CONTACT OF HER CHIN, THEN SPREADING TO WHERE THE CENTER OF THE DRESSING WAS IN CONTACT WITH THE SKIN. AFTER ADDITIONAL FOLLOW UP WITH THEIR CLINICIAN, AN ANTIBIOTIC AND ANTIHISTAMINE WERE PRESCRIBED. THE MOTHER REPORTED THE INITIAL CUT IS HEALING AND THE SKIN IS RED AND FLAKY. NO FURTHER INFORMATION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 17431370 ↗