MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE; SURGICAL DRAPE

Catalog Number	6650EZ
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product sample was not returned to 3m for analysis, and the lot number was not provided.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the exact root cause of the alleged injury or whether the 3m¿ ioban¿ 2 antimicrobial incise drape was the root cause.The product instructions for use (ifu) states the drape should be applied without tension.To remove drape, gently peel back drape at 180-degree angle from the skin.During the removal process hold onto the film with the thumb and hand as close as possible to the junction of skin and adhesive film.This prevents severe stretching.
Event or Problem Description
A hospital alleged an 92-year-old female experienced a right lateral hip skin tear upon postoperative removal of the 3m¿ ioban¿ 2 antimicrobial incise drape, 6650ez.The skin tear was noted as a minor injury that required medical treatment described as "dressings applied to keep the skin tear site clean and hopefully free of infection.".

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd ave south; po box 5227; brookings SD 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 16582321
• Report Number: 2110898-2023-00030
• Device Sequence Number: 11993295
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6650EZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 59 KG