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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M TEGADERM TRANSPARENT FILM DRESSING Back to Search Results
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.
 
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Brand Name3M TEGADERM TRANSPARENT FILM DRESSING
Type of DeviceTEGADERM 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 Key7336756
MDR Text Key102309608
Report Number2110898-2018-00028
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 Received03/13/2018
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 Received02/28/2018
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 Treatment Data
Date Received: 03/13/2018 Patient Sequence Number: 1
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