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

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A 8-month-old experienced a chest skin tear with post operative removal of a linen drape with 3m¿ ioban¿ 2 antimicrobial incise drape 6650ez that was allegedly stickier than usual.The clinician noted that a small round area of epidermis was removed, and during surgery nothing was taped or placed on top of the location where the skin tear occurred.Saline was applied to aid in drape removal, and gauze was applied to the area with no medication or treatment provided.No medical interventions were provided.
Additional Manufacturer Narrative
The product was not returned, and a two-year analysis confirmed no indication of an adverse trend of alleged injury with 3m¿ ioban¿ 2 antimicrobial incise drape, 6650ez.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.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 back at a 180-degree angle from the skin.3m¿ is unable to verify the leak and root cause without the sample.3m¿ will continue to monitor.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway avenue; st. paul MN 55144
• 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: 15456789
• Report Number: 2110898-2022-00083
• Device Sequence Number: 6842126
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2022

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 Expiration Date: 01/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 6650EZ
• Device Lot Number: 33J735
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2022
• 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 Age: 8 MO
• Patient Sex: Unknown
• Patient Race: Asian