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 Code	Skin Tears (2516)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for analysis.2 year trend analysis for ioban/incise drapes reporting an alleged injury does not indicate an adverse trend.It is unknown if skin preparations were used prior to drape application, and if neither the drape was applied under tension nor if other products were used to aid with drape removal.The product instructions for use (ifu) states the drape should be applied the drape should be removed by gently peeling it back at a 180-degree angle from the skin.End of report.
Event or Problem Description
Customer alleged a 15cm skin tear with the use of a 3m¿ ioban¿ 2 antimicrobial incise drape after surgery.No medical intervention was reported.No further information.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): 3M; 2510 conway avenue; st. paul MN 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: 15337483
• Report Number: 2110898-2022-00067
• Device Sequence Number: 17752012
• Product Code: KKX
• UDI-Device Identifier: 30707387444403
• UDI-Public: 30707387444403
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2022

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: 6650
• Device Lot Number: 33JEJ8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2022
• 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: 74 YR
• Patient Sex: Male
• Patient Race: Asian