3M™ Steri-Strip™ R1541Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30707387023677), received between Mar 24, 2022 and Mar 24, 2022 — 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 18, 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.

• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED FROM (B)(6): AN ALLERGIC REACTION WAS ALLEGED WITH USE OF 3M STERI-STRIP ADHESIVE SKIN CLOSURES THAT WERE APPLIED POST-SURGICALLY AND COVERED WITH A DRESSING AFTER A RIGHT TOTAL KNEE REPLACEMENT. NINE STRIPS WERE APPLIED AND REMOVED WHEN BLISTER(S) DEVELOPED. A PRE-SURGICAL ALCOHOL BODY WASH AND A SKIN PREPARATION WITH ALCOHOL AND CHLORHEXIDINE GLUCONATE WERE APPLIED. FOUR DAYS AFTER THE SURGERY, THE PATIENT WAS TRANSFERRED TO A REHABILITATION HOSPITAL, AND DRAINAGE WAS OBSERVED AROUND THE DRESSING. THE DRESSING WAS REMOVED, AND INFLAMMATION AND SWELLING AROUND THE AREA WAS OBSERVED. THE AREA WAS COVERED IN BETADINE, A COMPRESSION BANDAGE WAS APPLIED, AND FUROSEMIDE WAS PRESCRIBED ALONG WITH ANTIBIOTICS PROPHYLACTICALLY. IODINE HAD BEEN PLACED ON THE AREA AND IT WAS LEFT OPEN TO THE AIR AFTER REMOVAL OF THE DRESSING TEN DAYS LATER. THE SKIN FULLY HEALED. THE PATIENT WAS ALSO SEEING A PHYSIOTHERAPIST. DUE TO THE REACTION WITH FLUID AROUND THE KNEE, THE PATIENT ALLEGED A SETBACK WITH THE REHABILITATION THAT WAS PLANNED AND THAT THERE IS LESS MOBILITY IN THE KNEE.

  Patient problems: Blister; Pain; Swelling/ Edema

  MAUDE report 13875168 ↗