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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ulceration (2116)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the expiration date and date of manufacture could not be determined.The customer did not have a sample or lot number for the 3m¿ ioban¿ 2 antimicrobial incise drape used in this procedure.3m¿ ioban¿ 2 antimicrobial incise drapes are included in their procedure packs.The customer provided three different lot numbers for the procedure packs currently in stock.3m obtained information regarding the lot numbers for the ioban¿ drape contained in the procedure packs.There were three different lot numbers of 3m¿ ioban¿ 2 antimicrobial incise drapes in the procedure packs currently in stock.The customer reported chloraprep¿ was used for skin preparation prior to application of the 3m¿ ioban¿ 2 antimicrobial incise drape.A microscope (unspecified type) was used during the procedure.The cause of the skin injury remains unknown.
Event or Problem Description
Clinicians reported a patient experienced redness, blistering and skin pigment removal when a 6640ez 3m¿ ioban¿ 2 antimicrobial incise drape was removed following a spinal procedure.The patient initially experienced a 2" x 2" area of skin pigment removal and blistering when the drape was removed near the incision prior to skin closure.The remainder of the drape was removed without issue.Bacitracin ointment was initially used for treatment.The skin injury progressed to an ulceration and the patient was referred to a plastic surgeon.The nurse practitioner reported the patient will require a wound vac dressing and possible skin grafting.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: INCISE DRAPE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 7365784
• Report Number: 2110898-2018-00036
• Device Sequence Number: 13862213
• Product Code: KKX
• UDI-Device Identifier: 50707387559354
• UDI-Public: 50707387559354
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 6640EZSB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHLORAPREP¿; MICROSCOPE (UNSPECIFIED TYPE)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Weight: 7