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	Erythema (1840); Hemorrhage/Blood Loss/Bleeding (1888); Swelling (2091); Skin Tears (2516)
Date of Event	05/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographic: information was not provided.The sample is not available for return to 3m for analysis.Subcutaneous hemorrhage was reported.A clinical picture provided showed an incision on the neck and upper chest that were covered by 3m¿ ioban¿ 2 antimicrobial incise drape.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.The date of manufacturer of lot 2022-01 bd was january 9, 2020.
Event or Problem Description
A hospital pharmacist in (b)(6) reported that a 6635 3m¿ ioban¿ 2 antimicrobial incise drape was applied to a patient for surgery on (b)(6) 2020 (type of surgery unspecified).Subcutaneous bleeding of the front of the neck and upper chest in the areas of incision was observed.
Additional Manufacturer Narrative
Information was not provided.Updated description to add further information received.Updated to add further information received.Added additional adverse event terms and patient codes.Added method.
Event or Problem Description
A hospital pharmacist in (b)(6) reported that a 6635 3m¿ ioban¿ 2 antimicrobial incise drape was applied to a female patient for surgery on (b)(6) 2020 (type of surgery unspecified).Subcutaneous bleeding of the front of the neck and upper chest in the areas of incision was observed.Other symptoms included redness, swelling, and blisters under the area where the drape was placed, along with rash, skin stripping, skin tearing and maceration.The size of the rash was 4x5cm and occurred immediately post-operative.The drape was in place for approximately two hours before the symptoms began, no medical treatment was required for the symptoms, and the rash decreased over several days.Disinfectants (not specified) were used prior to placement of the drape.The skin was reported to be dry 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
• MDR Report Key: 10303604
• Report Number: 2110898-2020-00035
• Device Sequence Number: 14169356
• Product Code: KKX
• UDI-Device Identifier: 30707387444373
• UDI-Public: 30707387444373
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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 Expiration Date: 01/09/2022
• Device Model Number: N/A
• Device Catalogue Number: 6635
• Device Lot Number: 2022-01 BD
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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