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); Increased Sensitivity (2065); Skin Irritation (2076); Injury (2348)
Date of Event	03/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the expiration date and manufacture date could not be determined.The device was not returned for evaluation.The cause for this event is not clear and could not be established.The reporter did not provide specific information related to the product application and removal technique.No sample or lot number of the product were provided for further evaluation.The product instructions for use (ifu) states the drape should be applied without tension, and states that the drape should be removed by gently peeling it back at a 180-degree angle from the skin.The ioban drape instructions for use state that it is critical to employ the recommended technique for removal of this drape, particularly in patients with fragile skin.
Event or Problem Description
A female patient with parchment skin had a total shoulder prosthesis and allegedly experienced large skin lesions with pain when a 3m¿ ioban¿ 2 antimicrobial incise drape was removed that was placed from the front upper arm to the breast.The lesions were reported to be about 15x10cm ventral and 10x8cm dorsal of superficial nature.Treatment included regular dressing changes performed without anesthesia.Hyperesthesia in the area of the skin lesions was also observed.Bandages were changed daily.The skin healed in (b)(6) 2019.

• 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: 9083081
• Report Number: 2110898-2019-00110
• Device Sequence Number: 2623022
• Product Code: KKX
• UDI-Device Identifier: 30707387567164
• UDI-Public: 30707387567164
• Combination Product (Y/N): N
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 6661EZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention