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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Urticaria (2278)

Event Date 05/05/2019

Event Type  Injury  

Event Description

Allergic reaction to tegaderm bandage applied following abdominal surgery.Laparoscopic surgery performed on (b)(6) 2019.Three tegaderm bandage were applied - one at each incision from laparoscopic surgery.Allergic reaction consisted of hives that covered torso from under chest to public area and 6" down left and right legs.Hives were most concentrated around bandaged area and under breastbone.Tegaderm bandages were removed on (b)(6) 2019 as soon as the reaction occurred.My surgeon prescribed triamcinolone acetonide 0.1% topical cream as treatment for hives.As of (b)(6) 2019, hives are still present but to a lesser degree.I have a picture of the product.Fda safety report id# (b)(4).

• Brand Name: TEGADERM
• Type of Device: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): 3M COMPANY
• MDR Report Key: 8599908
• MDR Text Key: 144860098
• Report Number: MW5086526
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 54