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); Skin Erosion (2075); Skin Irritation (2076)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

Catalog number was unknown. Customer reported a tegaderm transparent film dressing (rectangular, size approximated at 4") was applied to this patient. Lot number was unknown. Without a lot number, an expiration date and manufacture date could not be determined. Etiology of the reaction was unknown. A two year complaint history was reviewed for the tegaderm transparent film dressing family and no trend was seen.

Event Description

A nurse reported a patient with acute lymphoblastic leukemia was receiving chemotherapy through a central catheter port located in her chest. A chlorhexidine based prep was used for skin preparation and a tegaderm transparent film dressing was used to cover her catheter site. The patient allegedly experienced redness and a weeping skin reaction. The tegaderm dressing was discontinued, the site was treated with a medihoney, hydrocolloid and another type of transparent film dressing and the patient was discharged from the hospital.

• 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: 7336757
• Report Number: 2110898-2018-00027
• 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: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 02/28/2018
• 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 Age: 18 MO
• Patient Outcome(s): Required Intervention