MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ COBAN¿ STERILE SELF-ADHERENT WRAP; BANDAGE, ELASTIC

Model Number	1584S
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Codes	Ulcer (2274); Blister (4537)
Date of Event	11/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient allegedly experienced postoperative ulceration with the use of 3m¿ coban¿ self-adherent wrap 1584l, lot 103923302.The largest blister was reportedly 4cm x 5cm, and the wound was subsequently disinfected with iodine.No medical interventions were reported.
Additional Manufacturer Narrative
Patient information: not provided.Product sample was not returned to 3m for analysis.3m¿ cannot determine the exact root cause of the alleged injury or whether a 3m¿ coban¿ sterile self-adherent wrap was the root cause.The instructions for use (ifu) states, this product contains natural rubber latex which may cause allergic reactions.3m will continue to monitor complaints and trends for this type of report.

• Brand Name: 3M¿ COBAN¿ STERILE SELF-ADHERENT WRAP
• Common Device Name: BANDAGE, ELASTIC
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd avenue south; 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: 16081289
• Report Number: 2110898-2022-00127
• Device Sequence Number: 20373263
• Product Code: FQM
• UDI-Device Identifier: 00707387802295
• UDI-Public: 00707387802295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2022

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 Expiration Date: 09/15/2026
• Device Model Number: 1584S
• Device Catalogue Number: 1584
• Device Lot Number: 103923302
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 12/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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