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 Code	Injury (2348)
Date of Event	01/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, weight: information was not provided.Lot #, device manufacture date: without a lot number, the expiration date and manufacture date could not be determined.Occupation: occupation of reporter was not provided.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.The ifu includes the notation that the skin of elderly patients is typically fragile and thus requires even greater care when applying and removing adhesive products such as drapes.
Event or Problem Description
A hospital employee in (b)(6) reported 6648 3m¿ ioban¿ 2 antimicrobial incise drapes were applied to a patient for cardiac surgery.The drapes were reportedly applied to intact skin.Alcoholic chlorhexidine was used for skin preparation.A circular skin injury in the thoracic/left breast area reportedly occurred when the drape was removed.(b)(6) gauze and a gauze dressing were applied to the site and secured with tape.Dermazine (sulfadiazine silver) was also reportedly used for treatment.

• 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: 8335697
• Report Number: 2110898-2019-00028
• Device Sequence Number: 2321584
• Product Code: KKX
• UDI-Device Identifier: 30707387444397
• UDI-Public: 30707387444397
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/13/2019

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: 01/15/2019
• Initial Report FDA Received Date: 02/13/2019
• 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: 63 YR