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 Code	Blister (4537)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
A 58-year-old male allegedly experienced severe blistering within 24 hours post application of a 3m¿ coban¿ self-adherent wrap, 1584, lot 103731727.The largest blister was reportedly 5cm x 9cm with water exudation observed at the bandage site.The area was disinfected with iodine.No medical interventions were reported.

• 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: dianne gibbs ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 15632459
• Report Number: 2110898-2022-00108
• Device Sequence Number: 12761697
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/19/2022

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: 05/25/2026
• Device Model Number: 1584S
• Device Catalogue Number: 1584
• Device Lot Number: 103731727
• 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: 09/28/2022
• Initial Report FDA Received Date: 10/19/2022
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male