MAUDE Adverse Event Report: 3M COMPANY STERI-DRAPE¿ IOBAN¿ 2; DRAPE, SURGICAL

Model Number	6619
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Burning Sensation (2146); Skin Tears (2516); Swelling/ Edema (4577)
Date of Event	04/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1-a6: not provided b3: date of event: (b)(6) 2023 - (b)(6) 2023, event occurrence time frame was provided.Specific date was not provided.D4 lot# & expiration date: not provided h4: manufacture date: not provided h10: product 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 definitively determine the root cause.The instructions for use states, the drape should be applied without tension and should be removed by gently peeling it back at a 180-degree angle from the skin.
Event or Problem Description
A nurse reported a patient allegedly experienced a 2nd degree skin avulsion localized to the incisional edges with surrounding area erythema, swelling, blisters, skin stripping/skin tear, burning sensation and pain postoperative removal of the 3m¿ steri-drape¿ large isolation drape with ioban¿ 2 incise film and pouch, 6619.No medical treatment was required to prevent death or serious injury, and it was noted there was an overall delay in wound healing, required pain management and wound care treatment, described as various wound therapy based on referral to occupational therapy and physical therapy for wound monitoring.The patient healed within 90 days with no permanent loss, with no known risk for permanent or functional impairment, no life-threatening conditions and did not required hospitalization.It was confirmed there was no difficulty removing the 3m¿ steri-drape¿ large isolation drape with ioban¿ 2 incise film and pouch, 6619, and no other products were used to aid with removal of the 3m product.

• Brand Name: STERI-DRAPE¿ IOBAN¿ 2
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): 3M COMPANY; 2510 conway ave.; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY; 2510 conway ave.; st. paul MN 55144
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17299448
• Report Number: 2110898-2023-00057
• Device Sequence Number: 17072630
• Product Code: KKX
• UDI-Device Identifier: 50707387444353
• UDI-Public: 50707387444353
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/11/2023

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: 6619
• Device Catalogue Number: 6619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/11/2023
• 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: Other
• Patient Sex: Unknown