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

Model Number	6651EZ
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot number and expiration date: not available.H4: manufacture date: not available.H10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.It was reported the drape was applied partially under tension.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.Skin of elderly patients is typically fragile and thus requires even greater care when applying and removing adhesive products such as drapes.
Event or Problem Description
Report received from the fda via medwatch report (b)(4).A risk manager reported a 76-year-old female allegedly experienced a left upper arm dime sized skin tear with the use of the 3m¿ ioban¿ 2 antimicrobial incise drape, 6651ez.No medical treatment was required to treat the reportedly minor injury, and for patient comfort only, an alternate dressing was subsequently applied it was also noted that there was no difficulty removing the 3m¿ ioban¿ 2 antimicrobial incise drape, 6651ez, and the product was partially applied under tension.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: IOBAN INCISE DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• 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: 17358370
• Report Number: 2110898-2023-00065
• Device Sequence Number: 6940891
• Product Code: KKX
• UDI-Device Identifier: 30707387793099
• UDI-Public: 30707387793099
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/18/2023

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 Model Number: 6651EZ
• Device Catalogue Number: 6651EZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 07/20/2023
• 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 Age: 76 YR
• Patient Sex: Male
• Patient Weight: 60 KG