3M™ Steri-Strip™ R1547Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30707387023646), received between Mar 19, 2019 and May 11, 2021 — classified as 4 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RASH WITH HIVES AND ITCHINESS AND SKIN HYPOPIGMENTATION WAS REPORTED AT THE INCISION SITE ON A RIB WHERE ONE 3M¿ STERI-STRIP¿ REINFORCED ADHESIVE SKIN CLOSURE WAS APPLIED AFTER A RHINOPLASTY WAS PERFORMED. THE SYMPTOMS WERE OBSERVED ABOUT ONE WEEK AFTER THE SURGERY, AND BETAMETHASONE 0.1% OINTMENT WAS PRESCRIBED AND APPLIED THREE TIMES A DAY FOR FOUR DAYS. THE SYMPTOMS RESOLVED EXCEPT FOR THE HYPOPIGMENTED AREA. THE SURGICAL INCISION IS HEALING.

  Patient problems: Rash; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 11810264 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED 3M¿ STERI-STRIP¿ COMPOUND BENZOIN TINCTURE AND 3M¿ R1547 REINFORCED STERI-STRIP¿ SKIN CLOSURES WERE APPLIED TO SEVEN PUNCTURE SITES ON HIS LEG FOLLOWING VARICOSE VEIN SURGERY. ONE WEEK FOLLOWING THE SURGERY HE HAD A FOLLOW-UP APPOINTMENT AND REDNESS WAS NOTED AT ALL SEVEN SITES. HE WAS REPORTEDLY GIVEN A RX FOR TRIAMCINOLONE ACETONIDE CREAM FOR TREATMENT. HE USED THE CREAM FOR THREE DAYS AND REPORTEDLY BROKE OUT IN A BODY RASH. HE WAS SEEN BY HIS SURGEON AND THE TRIAMCINOLONE ACETONIDE CREAM WAS DISCONTINUED. HIS SURGEON PRESCRIBED ORAL METHYLPREDNISOLONE. THE CONSUMER REPORTEDLY TOOK THE METHYLPREDNISOLONE FOR THREE DAYS AND WENT TO THE ER DUE TO FREQUENT URINATION. THE METHYLPREDNISOLONE WAS DISCONTINUED. THE CONSUMER CONSULTED AN ALLERGIST THE FOLLOWING DAY DUE TO THE UNRESOLVED BODY RASH AND WAS DIAGNOSED WITH CONTACT DERMATITIS. HE WAS REPORTEDLY TREATED WITH AN UNSPECIFIED RX CREAM.

  Patient problems: Erythema; Rash

  MAUDE report 8518795 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL IN FRANCE (B)(6) R1547 3M¿ STERI-STRIP¿ REINFORCED SKIN CLOSURES WERE APPLIED TO A PATIENT'S INCISION FOLLOWING AN ABDOMINOPLASTY. THE HOSPITAL ALLEGED THE PATIENT EXPERIENCED A PHLYCTEN (BLISTER) AND DESEPIDERMIZATION. THE STERI-STRIP¿ REINFORCED SKIN CLOSURES WERE REPORTEDLY DIFFICULT TO REMOVE. THE PATIENT ALLEGEDLY REQUIRED A PROLONGED HOSPITALIZATION FOR OBSERVATION.

  Patient problems: Skin Erosion

  MAUDE report 8433112 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HOSPITAL IN FRANCE REPORTED R1547 3M¿ STERI-STRIP¿ REINFORCED SKIN CLOSURES WERE APPLIED TO A PATIENT'S INCISION FOLLOWING A "TUMMY TUCK" PROCEDURE. THE HOSPITAL ALLEGED THE PATIENT EXPERIENCED ERYTHEMA, PRURITUS, AND LATER SUPERFICIAL NECROSIS AND INFECTION. THE PATIENT ALLEGEDLY REQUIRED A SURGICAL REVISION, NEGATIVE PRESSURE THERAPY AND HOSPITALIZATION.

  Patient problems: Erythema; Necrosis; Unspecified Infection

  MAUDE report 8433069 ↗