MAUDE Adverse Event Report: 3M TEGADERM; DRESSING, WOUND, OCCLUSIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

It was reported that the patient experienced an allergic reaction to the tagederm adhesive that was used to cover their implant incision.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TEGADERM
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): 3M
• MDR Report Key: 17524890
• MDR Text Key: 321137534
• Report Number: MW5131832
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1