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

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

Patient Problems Erythema (1840); Itching Sensation (1943); Local Reaction (2035)

Event Date 07/26/2017

Event Type  Injury  

Manufacturer Narrative

Customer did not have product catalog number, lot number or sample for this event.

Event Description

A (b)(6) female patient reportedly experienced itching and a red blotchy skin reaction when a tegaderm transparent dressing was applied to her breast following surgery.She initially used otc cortisone cream for treatment.Three days following removal of the dressing the area was still itching and the skin was reportedly bright red.She was seen by her md and was treated with a rx oral prednisone pack.She was also instructed to take zyrtec and apply a topical cortisone cream.

• 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: karen krenik ; 275 5w-06; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 6778697
• MDR Text Key: 82444115
• Report Number: 2110898-2017-00098
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 61 YR