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 07/01/2017

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.Customer reported this patient had a complex medical history.The patient reportedly had aplastic anemia, a bone marrow transplant, low platelet count and he developed graft- vs- host-disease.The patient had very sensitive skin and was on chemotherapy medication.A tegaderm transparent film dressing was reportedly applied one time in (b)(6) 2017.The patient reportedly expired in (b)(6) 2018, unrelated to use of the tegaderm transparent film dressing.

Event Description

A nurse reported a patient with aplastic anemia, bone marrow transplant and a complex medical history was receiving medication through a broviac central catheter.A chlorhexidine based prep was used for skin preparation and a tegaderm transparent film dressing was used one time in (b)(6) 2017 to cover the 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.

• 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: 7336756
• MDR Text Key: 102309608
• Report Number: 2110898-2018-00028
• 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: Nurse
• 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: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR