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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Tears (2516)

Event Date 08/25/2021

Event Type  Injury  

Manufacturer Narrative

The lot number was not reported and a sample was not available.The cause for this event is not clear and could not be established.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.End of report.

Event Description

Skin stripping of a top layer of skin was reported when a 3m ioban 2 antimicrobial incise drape, catalog 6648ez, was removed after a uni knee procedure.Skin preparation included chlorhexidine gluconate, followed by alcohol and then chloraprep®.Tegaderm was applied at the time of dressing on the surgical incision.

• Brand Name: 3M IOBAN 2 ANTIMICROBIAL INCISE DRAPE
• Type of Device: IOBAN INCISE DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 2510 conway ave; 3m center building 275-5w-06; st. paul, MN 55144-1000 ; 6517379117
• MDR Report Key: 12465351
• MDR Text Key: 271251155
• Report Number: 2110898-2021-00055
• Device Sequence Number: 1
• Product Code: KKX
• UDI-Device Identifier: 30707387793105
• UDI-Public: 30707387793105
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6648EZ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR