MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-DRAPE¿ U-DRAPE; DRAPE, SURGICAL

Model Number	1015
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the reporter is a health professional a sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether the 3m¿ steri-drape¿ u-drape was the root cause.
Event or Problem Description
On 01/19/2023, the following information was provided to 3m: the customer reported that the patient's skin allegedly lifted upon removal of the 3m¿ steri-drape¿ u-drape, 1015, lot 33kypx.No medical interventions were reported.3m made multiple unsuccessful follow up attempts to obtain additional information with no response.On 02/16/2023, 3m received fda via medwatch form mw1047429 that indicated medical treatment was required; however, specific information regarding the type of treatment provided was not specified. .
Event or Problem Description
A 92-year-old female allegedly experienced a skin tear upon postoperative removal of the 3m¿ steri-drape¿ u-drape, 1015, lot 33kypx.The skin tear was noted as a dime size minor injury that required medical treatment described as "dressings applied to keep the skin tear site clean and hopefully free of infection.".
Additional Manufacturer Narrative
H10: a sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to determine the root cause of the alleged injury or whether the 3m¿ steri-drape¿ u-drape was the root cause.
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¿ U-DRAPE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd ave south; po box 5227; brookings SD 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 16471781
• Report Number: 2110898-2023-00028
• Device Sequence Number: 20117094
• Product Code: PUI
• UDI-Device Identifier: 30707387018789
• UDI-Public: 30707387018789
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 1015
• Device Catalogue Number: 1015
• Device Lot Number: 33KYPX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/02/2023; 06/23/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/07/2023; 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: Disability; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White