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

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Skin Tears (2516)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned and the lot number was not provided.Based on the information provided, 3m is unable to determine that the cause of the incident is attributed to the 3m¿ ioban¿ 2 antimicrobial incise drape.Finished good release testing for adhesion to steel over the last year was reviewed and all products released were within specification.The product instructions for use (ifu) states the drape should be applied without tension.The ifu also states the drape should be removed by gently peeling it back at a 180-degree angle from the skin.
Event or Problem Description
A customer alleged a skin tear/skin removal with removal of a 3m¿ ioban¿ 2 antimicrobial incise drape post operative total knee replacement.Treatment includes weekly application of silvadene® cream and keflex® for three weeks.The customer bruises easily and experiences pain with dressing changes.Two tablets of 650mg tylenol are taken twice a day for pain.The wound is healing; however, physical therapy was this initially delayed.Range of motion has now improved.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): 3M; 2510 conway avenue; st. paul 55144 1000
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd avenue south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15222261
• Report Number: 2110898-2022-00058
• Device Sequence Number: 12442693
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

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 Model Number: N/A
• Device Catalogue Number: 6650EZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/12/2022
• 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 Age: 80 YR
• Patient Sex: Female