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 Codes	Burn(s) (1757); Blister (4537)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A hospital materials manager of surgical services reported that a patient developed blisters on a leg with use of 3m ioban 2 antimicrobial incise drape was applied for a surgical procedure.The patient was seen by the hospital surgeon and was provided an unspecified ointment to treat the blisters and was instructed to follow-up in the office.3m duraprep surgical solution was applied for surgical skin preparation.Vascular surgery nurse informed that upon removing the drape, a burn/blister was noticed.
Additional Manufacturer Narrative
Pt information: not provided.No sample was returned for analysis and no lot number was provided.During follow-up with hospital staff, the surgeon and anesthetist reported that 3m ioban 2 antimicrobial incise drape was not the cause of the symptom, rather the surgical lights since they were very hot and had not been calibrated; the surgeon has used the drapes for years without issue.The nurse had not noticed anything unusual in the application or removal of the drape.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: 12962154
• Report Number: 2110898-2021-00071
• Device Sequence Number: 13901266
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2021

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: 6650EZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3M DURAPREP SURGICAL SOLUTION.; OPERATING ROOM LIGHT.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female