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

Model Number 1584S

Device Problem Inadequate User Interface (2958)

Patient Problems Ulcer (2274); Blister (4537)

Event Date 11/16/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 306496501
• Report Number: 2110898-2022-00127
• Device Sequence Number: 1
• Product Code: FQM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1584S
• Device Catalogue Number: 1584
• Device Lot Number: 103923302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other