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	Pain (1994); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)
Date of Event	07/01/2020
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 cause for this event is not clear and could not be established.The drape was in place for 24 hours before the symptoms began.Chlorhexidine gluconate was applied as a skin preparation prior to application of the drape.Information related to the product application and removal technique was not known.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
An allergist reported that a patient experienced skin redness, itchiness, burning sensation and pain after a surgical procedure in (b)(6) 2020 where a 3m¿ ioban¿ 2 antimicrobial incise drape, catalog 6650ez, was placed.Chlorhexidine gluconate was applied as a skin preparation before the drape was placed.The drape was in place for 24-hours before the symptoms began.Type of surgery performed and anatomical location of the drape was not reported.A course of prednisone was prescribed, taken less than a week, and 2.5% hydrocortisone cream was applied for one week to the affected area.The symptoms fully resolved within one to two weeks.

• 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: 10864883
• Report Number: 2110898-2020-00061
• Device Sequence Number: 2635493
• Product Code: KKX
• UDI-Device Identifier: 30707387507351
• UDI-Public: 30707387507351
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6650EZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/18/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention