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

Model Number	6650EZ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1-6 patient information is unknown.D4: lot and expiration date are unknown.H4: manufacturer date is unknown.H10: the complaint was received without a specific catalog number or 3m id number.This mdr will be processed using catalog number 6650ez.If during investigation it is identified as a different catalog number, a supplemental report will be submitted.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 dry 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
A hospital reported a surgical patient underwent a four-to-five-hour first rib resection procedure.The patient's skin was prepped with chloraprep and a ioban drape was used as part of the sterile drape.The drape was placed on the patient's left side of the neck and upper chest area.Postoperative the patient reported burning to the surgical area.After approximately eight to twelve hours after application the skin was assessed.The surgeon alleged blisters and initially thought it was a burn from the operating room lights.A plastic surgeon was consulted, silvadene ointment followed by steroid injections and scar excision were performed.The lights were inspected on the max intensity; although they were unable to confirm if the lights did indeed cause the burn like symptoms.The plastic surgeon seems to think this may be a chemical reaction from either the ioban drape or combination of the drape and chloraprep.The patient is doing well and is pleased with the results of the scar excision surgery.

• 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: 17095106
• Report Number: 2110898-2023-00050
• Device Sequence Number: 1988702
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: 6650EZ
• Device Catalogue Number: 6650EZ
• 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: 05/09/2023
• Initial Report FDA Received Date: 06/08/2023
• 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: Required Intervention
• Patient Sex: Unknown