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	08/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The exact lot number was not reported.In the operatory area, records of the lot number used was not maintained.The distributor reported that the hospital ordered two lot numbers (as listed in the lot number field).The cause for this event is not clear and could not be established.Information related to the product application and removal technique was not known.The cause of epidermal layer peel is clearly multifactorial and beyond performance of the 3m¿ ioban¿ 2 antimicrobial incise drape 6650 alone.Patient existing health condition and surgery duration are the possible causes of skin injury, such as patient skin sensitivity due to liver failure, manifestation of abdominal swelling and very long hours of surgery with skin exposure to irrigations and retractors.There is no clear cause relationship to product use.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 or Problem Description
Received from (b)(6): a patient that was diagnosed with liver failure underwent a liver transplant surgery and developed skin stripping and skin tears.A 3m ioban 2 antimicrobial incise drape, catalog 6650, was applied on the left side of the abdomen after surgical site preparation that consisted of shaving and application of 10% povidone iodine followed by alcohol for three times.After twelve hours of drape wear, three skin peels/epidermal loss/possible marsi were observed near the incision site, described as two small skin tears were observed over upper left quadrant of the abdomen (2cm x 2cm) and one in the lower left quadrant (3cmx3cm) that were observed near the drape edges and suture sites.The skin was reported as dry prior to drape application.No medical treatment was provided for the symptoms; the area was covered with routine post-operative dressings per protocol.The patient is in the icu post-liver transplant surgery.Skin injury post-incidence was not observed.

• 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
• MDR Report Key: 12425454
• Report Number: 2110898-2021-00053
• Device Sequence Number: 16013618
• Product Code: KKX
• UDI-Device Identifier: 30707387444403
• UDI-Public: 30707387444403
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/03/2021

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: 33CK9Y, 33DNM4
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2021
• Initial Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR