MAUDE Adverse Event Report: 3M BROOKINGS 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE; SURGICAL DRAPE

Catalog Number	6640
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	06/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned and a two-year analysis confirmed no indication of an adverse trend of alleged injury with 3m¿ ioban¿ 2 antimicrobial incise drape, 6640.Based on the information provided, 3m is unable to determine that the cause of the incident is attributed to the 3m¿ ioban¿ 2 antimicrobial incise 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 back at a 180-degree angle from the skin and to take greater care when applying and removing adhesive products such as drapes on those with fragile skin.3m¿ is unable to verify the leak and root cause without the sample.3m¿ will continue to monitor.
Event or Problem Description
A 6-month-old allegedly experienced left chest superficial skin tears with post operative removal of 3m¿ ioban¿ 2 antimicrobial incise drape, 6640.The alleged skin tears were dressed with duoderm® dressings and treated with mupirocin antibiotic topical ointment with wound care.Upon discharge, the skin tear area reportedly appeared pink with a scab and no signs of infection.

• Brand Name: 3M¿ IOBAN¿ 2 ANTIMICROBIAL INCISE DRAPE
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): 3M BROOKINGS; 601 22nd avenue south; brookings SD 57006
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd avenue south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15469737
• Report Number: 2110898-2022-00089
• Device Sequence Number: 4281483
• Product Code: KKX
• UDI-Device Identifier: 30707387444380
• UDI-Public: 30707387444380
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K801550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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 Catalogue Number: 6640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American