MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE; DRAPE SURGICAL

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Skin Tears (2516)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample is pending return for analysis.A skin preparation was not used prior to drape application.It is also unknown if the drape was applied under tension.End of report.
Event or Problem Description
A materials manager reported that a patient allegedly experienced a 5cm x 1.5cm full thickness arm skin tear from a 3m¿ steri-drape¿ large towel drape with minimal bleeding that resolved with pressure.The surgeon subsequently reapplied the skin with skin glue, and the wound is improving.A skin preparation was applied post 3m¿ steri-drape¿ large towel drape application.No other products were applied prior to the application of the drape.
Additional Manufacturer Narrative
H10: 3m has investigated and identified the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and may render the product unusable.Additionally, 3m has observed an increase in reported adhesive related skin injuries for these affected lots, although the acceptance for the device was met upon product release, the adhesive component may not meet 3m's performance criteria throughout product shelf life.3m requests customers cease use of the product and quarantine it for destruction/disposal.3m has initiated a voluntary recall of select models and lots of 3m¿ steri-drape¿ surgical drapes distributed between october 29, 2021 - august 25, 2022.Corrective action will be taken for this issue and will continue to monitor.

• Brand Name: 3M¿ STERI-DRAPE¿ LARGE TOWEL DRAPE
• Common Device Name: DRAPE SURGICAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: dianne gibbs ; 2510 conway ave; 3m center building 275-5w-06; st. paul, MN 55144-1000 ; 6517379117
• MDR Report Key: 15251242
• Report Number: 2110898-2022-00057
• Device Sequence Number: 6355405
• Product Code: PUI
• UDI-Device Identifier: 30707387057252
• UDI-Public: 30707387057252
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

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: 1010NSD
• Device Lot Number: 33JE6A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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; Disability
• Patient Age: 89 YR
• Patient Sex: Female