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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM DRESSING TEGADERM¿ DRESSING

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3M HEALTH CARE 3M TEGADERM DRESSING TEGADERM¿ DRESSING Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Reaction (2414)
Event Date 05/21/2018
Event Type  Injury  
Manufacturer Narrative
Date of event was unknown. The patient was seen in the clinic on (b)(6) 2018 and this date was used for the date of the event. Catalog and lot numbers were not known. Without a catalog and lot number, expiration date and manufacture date could not be determined. The cause of the reaction could not be determined. The reporter did not have a catalog, lot number or sample available for analysis. The patient also reportedly experienced a reaction to an adhesive closure device following a total knee replacement. An mdr was submitted for this adverse event because a rx topical ointment may have been applied for treatment of the reported reaction. End of report.
 
Event Description
A nurse from a dermatology clinic reported a patient experienced a scrape on her right medial ankle following removal of her compression socks. The nurse alleged a tegaderm¿ dressing was applied to the area. The patient reportedly experienced a reaction described as "black hemorrhagic skin and some erosion". The nurse reported the patient may have used rx lidex 0. 5% ointment for treatment of the reaction.
 
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Brand Name3M TEGADERM DRESSING
Type of DeviceTEGADERM¿ 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
dianne gibbs
275 5w-06
st. paul, MN 55144
6517379117
MDR Report Key7719555
MDR Text Key115010975
Report Number2110898-2018-00079
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 health professional,other
Reporter Occupation
Type of Report Initial
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2018
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: 07/25/2018 Patient Sequence Number: 1
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