Steri-Drape™ 1010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30707387057252), received between Mar 30, 2020 and Aug 18, 2022 — classified as 3 injuries.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 6, 2022Open, Classified

   During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable. Additionally, 3M has observed an increase in reported adhesive related skin injuries for these affected lots.

   Z-0250-2023 · Root cause: Component change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MATERIALS MANAGER REPORTED THAT A PATIENT ALLEGEDLY EXPERIENCED A 5CM X 1.5CM FULL THICKNESS ARM SKIN TEAR FROM A 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE WITH MINIMAL BLEEDING THAT RESOLVED WITH PRESSURE. THE SURGEON SUBSEQUENTLY REAPPLIED THE SKIN WITH SKIN GLUE, AND THE WOUND IS IMPROVING. A SKIN PREPARATION WAS APPLIED POST 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE APPLICATION. NO OTHER PRODUCTS WERE APPLIED PRIOR TO THE APPLICATION OF THE DRAPE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Tears

  MAUDE report 15251242 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT A PATIENT DEVELOPED SUSPECTED CONTACT DERMATITIS, DESCRIBED AS SKIN RASH WITH REDNESS, ITCHINESS AND BLISTERS ALONG THE DRAPE EDGES AFTER APPLICATION OF A 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE 1010 DURING SPINAL SURGERY. THE RASH IS LOCATED ON THE ANTERIOR NECK/SUPERIOR TORSO REGION, SIZE REPORTED AS GREATER THAN 25X6CM AT THE LARGEST LINEAR REGION. SKIN PREPARATION INCLUDED APPLICATION OF MASTISOL® LIQUID ADHESIVE. THE SKIN WAS REPORTED AS DRY PRIOR TO APPLICATION OF THE DRAPE. THE DRAPE WAS IN PLACE 1-2 DAYS BEFORE THE SYMPTOMS BEGAN. MEDICAL TREATMENT CONSISTED OF INTRAVENOUS, ORAL, AND TOPICAL CORTICOSTEROIDS. HEALING IS IN PROGRESS AND THE PATIENT IS REPORTED AS IN STABLE CONDITION.

  Patient problems: Erythema; Itching Sensation; Rash

  MAUDE report 10376373 ↗
• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ANAPHYLACTIC REACTION WAS REPORTED THAT OCCURRED SIX DAYS AFTER A CERVICAL FUSION SURGERY PROTECTED BY A 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE 1010. A MEDICAL ALERT BAND WAS WORN THE DAY OF SURGERY DUE TO PRIOR SKIN REACTIONS WITH ADHESIVES. THE CONSUMER WENT TO THE EMERGENCY ROOM SIX DAYS AFTER SURGERY DUE TO SYMPTOMS OF FACIAL ITCHINESS WITH A BURNING SENSATION AND FACIAL AND THROAT SWELLING. AN INTRAVENOUS INFUSION OF DIPHENHYDRAMINE AND A STEROID WAS ADMINISTERED, AND THE SYMPTOMS RESOLVED. THE CONSUMER WAS DISCHARGED FROM THE EMERGENCY ROOM THE SAME DAY. SKIN REDNESS UNDER THE ADHESIVE AREA OF THE 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE 1010 WAS ALSO OBSERVED.

  Patient problems: Anaphylactic Shock; Burning Sensation; Erythema; Itching Sensation; Swelling

  MAUDE report 9899124 ↗