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

Model Number	6650
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Blister (4537)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A female patient was prepped with chloraprep¿ for a 1st rib surgical resection and 3m¿ ioban¿ 2 antimicrobial incise drape, 6650 was applied as part of the sterile drape.Postoperatively, the patient allegedly experienced a burning sensation to the left neck/clavicular surgical site, and the 3m¿ ioban¿ 2 antimicrobial incise drape, 6650 reportedly remained intact.Approximately 12 hours postoperative, the surgical site was assessed and erythema with blistering at the surgical site were observed.The surgical site has healed, however, the areas resulted in significant keloid scarring, with two scars, one approximately 5 cm and one approximately 7cm.The patient is under the care of a plastic surgeon who plans to perform reconstructive surgery to revise the scars in 2023.
Additional Manufacturer Narrative
Expiration date & manufacture date: not available.Product sample was not returned to 3m for analysis.Without a sample available, it is not possible to evaluate the sample for any defects or perform any tests to determine if the product met specification.3m¿ cannot determine the exact root cause of the alleged injury or whether the 3m¿ ioban¿ 2 antimicrobial incise drape was the root cause.The skin prep, chloraprep¿, was reportedly applied to the patient prior to the application of the drape.It is unknown if the 3m¿ ioban¿ 2 antimicrobial incise drape was applied under tension.The product instructions for use (ifu) states the drape should be applied 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: SURGICAL DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd avenue south; 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: 16081283
• Report Number: 2110898-2022-00128
• Device Sequence Number: 17665539
• Product Code: KKX
• UDI-Device Identifier: 30707387444403
• UDI-Public: 30707387444403
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K974553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/31/2022

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: 6650
• Device Catalogue Number: 6650
• 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: 12/06/2022
• Initial Report FDA Received Date: 12/31/2022
• 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: Other; Disability
• Patient Sex: Female