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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch 0500770000-2022-8017 was received from the fda: an elderly patient with large skin tear on lower extremity.Ioban 2 wound dressing was being removed after cardiac surgical procedure.It was noted when the drape was being removed from the lower extremity, the patient's skin was adhered to the drape.The staff made attempts to carefully remove the remaining drape.It was difficult to see that additional skin was adhered and when the drape was completely removed, the skin tear was noted.The patient will follow up for wound care.Additional information received upon follow-up with the reporter: when the surgical procedure was completed, the 3m ioban 2 antimicrobial incise drape was removed slowly by the operating room staff, from the chest down towards the right lower extremity, and it was noted that some of the paper-thin skin was adhered to the drape.The remaining parts of the dressings were removed and after the drape was completely removed, it was identified that a large portion of the skin was sheared on the lower right extremity.It was difficult to confirm the skin was adhered to the remaining part of the drape due to his paper-thin skin blending into the drape.A xeroform dressing was applied with home health for dressing changes.
Additional Manufacturer Narrative
Patient identifier, age or date of birth, weight, ethnicity and race: not provided.No sample was returned for analysis and no lot number was provided.It is unknown if skin preparations were used prior to drape application and it is also unknown if the drape was applied under tension.No other products were used to aid with drape removal.Skin condition was reported as paper-thin prior to drape removal.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.

• 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
• 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: 14627265
• Report Number: 2110898-2022-00036
• Device Sequence Number: 4574306
• Product Code: KKX
• UDI-Device Identifier: 30707387507382
• UDI-Public: 30707387507382
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/07/2022

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: 6651EZ
• Device Lot Number: UNKNOWN
• 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: 05/20/2022
• Initial Report FDA Received Date: 06/07/2022
• 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: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 69 KG