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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); 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.
 
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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 Key6778697
MDR Text Key82444115
Report Number2110898-2017-00098
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 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 Received08/09/2017
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? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/28/2017
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 Treatment Data
Date Received: 08/09/2017 Patient Sequence Number: 1
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