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	Erythema (1840); Pain (1994); Skin Tears (2516); Blister (4537); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	05/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Without a lot number, the expiration date and manufacture date could not be determined.No sample was returned for analysis and no lot number was reported.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.End of report.
Event or Problem Description
Received report on 03dec2020 from clinical specialist reporting skin burn/skin tear on the chest of an (b)(6) day old infant.Customer uses chloroprep as surgical prep.The customer uses dermabond and mepilex on chest post op.No other information for this patient was received.4 other incidents were mentioned in this report - however, there was no patient specific information for those incidents.
Additional Manufacturer Narrative
Sample was not returned for analysis.During follow-up with hospital staff, it was learned that new surgical headlights were used.As new surgical lights were used, it may be possible that the symptoms may have been the result of excess heat generated and/or the vicinity of the light placed in proximity to the surgical area.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.End of report.
Event or Problem Description
An operating room manager reported skin redness, blisters, burning, pain and a skin tear on the left chest wall of an infant.The 3m¿ ioban¿ 2 antimicrobial incise drape was on the skin for more than three hours.Wound care team intervention was required.Chlorhexidine gluconate was applied for surgical skin preparation.Dermabond® and mepilex® dressing were applied post-operatively.

• 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: 11067529
• Report Number: 2110898-2020-00066
• Device Sequence Number: 19159316
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): Y
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2021

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: 07/20/2022
• Device Model Number: N/A
• Device Catalogue Number: 6650EZ
• Device Lot Number: 339PAH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/15/2021
• 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: CHLORHEXIDINE GLUCONATE; SUNOPTIC SURGICAL HEADLIGHT.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 4 MO
• Patient Weight: 6