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	Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/05/2020
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.Initial reporter's phone # and email address were not provided.Initial reporter's occupation not provided.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 customer did not provide information related to the product application and removal technique.The surgical procedure was reported as being eight hours in duration and no skin preparation products were applied prior to application of the drape.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
Skin stripping of the epidermis and discomfort upon removal of the drape was reported for a patient in (b)(6) who underwent an eight-hour bypass surgery on an area underneath a 3m¿ ioban¿ 2 antimicrobial incise drape 6648 that had been placed.No skin preparation products had been applied an prior to application of the drape.

• 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: 10737680
• Report Number: 2110898-2020-00053
• Device Sequence Number: 14234381
• Product Code: KKX
• UDI-Device Identifier: 30707387444397
• UDI-Public: 30707387444397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 6648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 10/26/2020
• 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