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); Injury (2348)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt id, ethnicity, & race: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.A clinical picture provided showed a superficial wound.A big area was covered with ioban, however only a small region showed skin tears.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 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
A hospital employee in (b)(6) reported that 6648 3m¿ ioban¿ 2 antimicrobial incise drapes were applied to a patient for left hip replacement surgery.Chlorhexidine was used for skin preparation.A circular superficial skin injury approximately 1cm from the surgical incision site about 5cm in diameter occurred when the ioban drape was removed.The skin was cleaned with sodium chloride and a medipore¿ + pad soft cloth adhesive wound dressing was applied.There was no sign of infection upon hospital discharge.The patient later saw a general practitioner who prescribed a 7-day course of antibiotic for a suspected infection.

• 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: 8829127
• Report Number: 2110898-2019-00091
• Device Sequence Number: 11478127
• Product Code: KKX
• UDI-Device Identifier: 30707387444397
• UDI-Public: 30707387444397
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 6648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/25/2019
• 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
• Patient Age: 58 YR
• Patient Weight: 119