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

Catalog Number	6650EZ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1-a6: not provided.B3: date of events: not provided.D4: lot number and expiration date: not available.H4: manufacture date: not available.H10: product samples were not returned to 3m for analysis, and the lot number provided was not valid.Without samples, it is not possible to perform any tests to determine if the devices met specifications.Without additional information, it is not possible to determine the exact root cause of the alleged injuries or whether the 3m¿ ioban¿ 2 antimicrobial incise drapes were 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 reported two patients allegedly experienced skin tears with removal of the 3m¿ ioban¿ 2 antimicrobial incise drape, 6650ez.The physician confirmed no patient information is available.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): 3M BROOKINGS; 601 22nd ave south; po box 5227; brookings SD 57006
• 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: 17940279
• Report Number: 2110898-2023-00090
• Device Sequence Number: 6350697
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 10/16/2023
• 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: Other
• Patient Sex: Unknown