MAUDE Adverse Event Report: 3M COMPANY MICROPORE SURGICAL TAPE; TAPE AND BANDAGE, ADHESIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Inflammation (1932); Scar Tissue (2060)

Event Date 09/01/2021

Event Type  Injury  

Event Description

While in the hospital in the united states; micropore tape by 3m was use on the reporter and caused inflammation and scarring."it is not hypoallergenic; it attacked my skin and was very aggressive.I want it removed from the shelves and for no one to have the reaction that i did".

• Brand Name: MICROPORE SURGICAL TAPE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 12682395
• MDR Text Key: 278421954
• Report Number: MW5104897
• Device Sequence Number: 1
• Product Code: KGX
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR