Steri-Drape™ 1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30707387018789), received between Sep 24, 2021 and Mar 2, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Human-Device Interface 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ON 01/19/2023, THE FOLLOWING INFORMATION WAS PROVIDED TO 3M: THE CUSTOMER REPORTED THAT THE PATIENT'S SKIN ALLEGEDLY LIFTED UPON REMOVAL OF THE 3M¿ STERI-DRAPE¿ U-DRAPE, 1015, LOT 33KYPX. NO MEDICAL INTERVENTIONS WERE REPORTED. 3M MADE MULTIPLE UNSUCCESSFUL FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WITH NO RESPONSE. ON 02/16/2023, 3M RECEIVED FDA VIA MEDWATCH FORM MW1047429 THAT INDICATED MEDICAL TREATMENT WAS REQUIRED; HOWEVER, SPECIFIC INFORMATION REGARDING THE TYPE OF TREATMENT PROVIDED WAS NOT SPECIFIED.

  Patient problems: Skin Tears

  MAUDE report 16471781 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INTENSE ITCHINESS AND A RASH DEVELOPED UNDER THE EDGE OF A 3M STERI-DRAPE U-DRAPE THAT WAS APPLIED DURING A PARTIAL LEFT HIP REVISION SURGERY. DIPHENHYDRAMINE WAS ADMINISTERED INTRAVENOUSLY, AND THE SYMPTOMS RESOLVED. THE ITCHINESS OCCURRED ON THE CHEST BELOW THE BREAST AREA AFTER THE SURGERY ENDED AND THE RASH WAS OBSERVED WHEN THE DRAPE WAS REMOVED. CHLORHEXIDINE GLUCONATE WAS USED FOR SKIN PREPARATION PRIOR TO THE SURGERY; SKIN PREPARATION PRODUCTS APPLIED AT THE REACTION SITE IS UNKNOWN.

  Patient problems: Itching Sensation; Rash

  MAUDE report 12530413 ↗