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U.S. Department of Health and Human Services

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

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3M HEALTH CARE 3M TEGADERM TRANSPARENT FILM DRESSING TEGADERM¿ DRESSING Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wheal(s) (2241); Reaction (2414)
Event Date 05/05/2019
Event Type  Injury  
Manufacturer Narrative
Catalog #, lot #, manufacture date: product information (catalog, lot number) was not provided. Without a lot number, expiration date and manufacture could not be determined. Initial reporter also sent report to fda: mw5086526 received from the fda. Multiple studies are regularly conducted that have demonstrated appropriate device biocompatibility and safety performance criteria when the device is used appropriately on humans. In addition to ensuring biocompatibility and safety performance, 3m closely monitors its manufacturing, controlling the release and functional characteristics of these medical devices. Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products. To monitor these situations, medical complaints are trended either in aggregate or in categories allowing for appropriate corrective action to be taken if the trend deviates from historical values.
 
Event Description
The fda notified 3m of an adverse event via a medwatch report. A consumer reported the following information to the fda: "allergic reaction to tegaderm bandage applied following abdominal surgery. Laparoscopic surgery preformed on (b)(6) 2019, three tegaderm bandages were applied- one at each incision from laparoscopic surgery. Allergic reaction consisted of hives that covered torso from under chest to public area and 6" down left and right legs. Hives were most concentrated around bandaged area and under breastbone. Tegaderm bandages were removed on (b)(6) 2019 as soon as the reaction occurred. My surgeon prescribed triamcinolone acetonide 0. 1% topical cream as treatment for hives. As of (b)(6) 2019 hives are still present but to a lesser degree. I have a picture of the product. ".
 
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Brand Name3M TEGADERM TRANSPARENT FILM 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 Key8678756
MDR Text Key147327534
Report Number2110898-2019-00080
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,other
Reporter Occupation
Type of Report Initial
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2019
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: 06/07/2019 Patient Sequence Number: 1
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