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	Skin Tears (2516); Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.A lot number was reported.Internal tests results, generated at the time of manufacture, were reviewed.Also, samples from the lot were tested; each of the test results for lot 337ldl were within specification.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.Such reactions are likely not entirely related to ioban; adverse symptoms may possibly be due to the surgical procedure that most likely involved tissue manipulation, electrocautery, lift of the drape related to placement of the sternal retractor, irrigation, mechanisms of which may include superficial soft tissue ischemia (compromise of blood supply) and trauma.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.
Event or Problem Description
Received from (b)(6): a patient had cardiac bypass surgery with valve replacement and ablation developed skin redness, swelling and blisters that bled on both sides of the incision.Skin preparation included placement of a 3m¿ ioban¿ 2 antimicrobial incise drape, catalog 6650, after application and drying of an iodophor preparation that covered a larger area than the drape.Other devices used included a negative plate placed on the thigh, electrodes placed outside the skin area, and an incision spreader.A second case was reported for a cardiac surgery where an incision spreader was also used; case specific information was not provided.
Additional Manufacturer Narrative
Corrected device manufacturer date.
Event or Problem Description
Received from china: a patient had cardiac bypass surgery with valve replacement and ablation developed skin redness (3x5cm) swelling (10x12cm), blisters and a skin tear on both sides of the incision after removal of a 3m¿ ioban¿ 2 antimicrobial incise drape, catalog 6650 near the incision along the mid-sternum line to the neck.Skin preparation included application of an iodophor preparation that covered a larger area than the drape.The drape was in place for approximately five hours.Other devices used included a negative plate placed on the thigh, electrodes placed outside the skin area, and an incision spreader.A second case was reported for a cardiac surgery where an incision spreader was also used; case specific information was not provided.The skin recovered for both patients.

• 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: 11223751
• Report Number: 2110898-2021-00003
• Device Sequence Number: 742486
• Product Code: KKX
• UDI-Device Identifier: 30707387444403
• UDI-Public: 30707387444403
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2021

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 Expiration Date: 01/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 6650
• Device Lot Number: 337LDL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 10/21/2020
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/03/2021; 03/02/2021
• 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: INCISION SPREADER; IODOPHORS; INCISION SPREADER; IODOPHORS
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR