MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM TRANSPARENT FILM DRESSING; TEGADERM¿ TRANSPARENT FILM DRESSING

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Reaction (2414); Skin Inflammation (2443)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

Weight: information was not provided.Initial reporter: email address was not provided.End of report.

Event Description

A consumer alleged she experienced a bright red rash, itching, bruising, pain, swelling and elevated liver enzymes following use of a 1624w 3m¿ tegaderm¿ transparent film dressing.The dressing was used to secure a gauze sponge over an abdominal incision following surgery for a cyst removal.The reaction reportedly progressed and spread beyond the area where the dressing was applied.She saw her physician and was treated with a topical prescription for mometasone cream.She also reportedly used otc antihistamines for treatment.She reported the reaction was slowly resolving but the skin was still tender.

• Brand Name: 3M TEGADERM TRANSPARENT FILM DRESSING
• Type of Device: TEGADERM¿ TRANSPARENT FILM DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: brendan casey, ph.d. ; 275 5w-06; st. paul, MN 55144 ; 6517374488
• MDR Report Key: 7436209
• MDR Text Key: 105672794
• Report Number: 2110898-2018-00042
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1624W
• Device Lot Number: 2018-06-PD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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): Required Intervention
• Patient Age: 49 YR