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

Model Number	N/A
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 determine the exact root cause of the alleged injury or whether the 3m¿ ioban¿ 2 antimicrobial incise drape was the root cause.It is unknown if skin preparations were used prior to drape application, and it is also unknown if the drape was applied 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 via medwatch form 4600610000-2023-8004.A hospital health representative reported a 62-year-old male allegedly experienced a 2 cm superficial epidermal skin strip upon post operative removal of the 3m¿ ioban¿ 2 antimicrobial incise drape, 6650ez lot 33ntjj.No other skin was peeled away from the patient with the 3m¿ ioban¿ 2 antimicrobial incise drape, and normal skin edges were reportedly still present at the incision site.The wound was closed, and 0.5-1ml of bacitracin antibiotic ointment 500 units/gram was applied to treat the area.Dermabond advanced® topical skin adhesive was placed along the incision site with telfa dressing and 3m¿ medipore¿ surgical tape.

• 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: 16916943
• Report Number: 2110898-2023-00045
• Device Sequence Number: 6931211
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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 Expiration Date: 03/15/2025
• Device Model Number: N/A
• Device Catalogue Number: 6650EZ
• Device Lot Number: 33NTJJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 98 KG