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U.S. Department of Health and Human Services

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

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3M HEALTH CARE NEXCARE TEGADERM WATERPROOF TRANSPARENT DRESSING TEGADERM¿ DRESSING Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
Event Date 09/06/2021
Event Type  Injury  
Manufacturer Narrative
Patient information: information was not provided. No sample has been received for analysis. The 2-year complaint history was reviewed for the product's global sales code (gsc) of szn and reported failure. No trends were observed. 3m will continue to monitor. Testing confirms the biocompatibility of nexcare¿ tegaderm¿ transparent dressings for their intended use. In addition to performing clinical studies, 3m monitors its medical devices with manufacturing controls including in-process and release specifications/testing. Despite these studies and controls, a percent of the population is sensitive to adhesive products. End of report.
 
Event Description
A female customer (age unspecified) reported an incident regarding the nexcare¿ tegaderm¿ transparent dressing. On an unspecified date, she fell in her backyard. On (b)(6) 2021, per her doctor's recommendation, the tegaderm¿ transparent dressing was applied to her bilateral legs (exact location was unspecified) and her right upper arm covering the skin tears/scrapes she got from the fall. She reported that a nurse cleansed the wound with an unspecified antiseptic before the dressing was placed. She changed the dressing on (b)(6) 2021. On an unspecified date, she allegedly noticed black, white and green bubbles under the dressing. On (b)(6) 2021, the wound was cultured and dressed differently (details were not provided). She went back to the doctor on (b)(6) 2021. The doctor allegedly noticed a colorless drainage with slight odor draining from all three areas where the bandage was applied. The doctor took culture, cleansed each wound (details were not provided), applied an antiseptic pad and the covered with gauze. The doctor also prescribed her cephalexin antibiotics. The doctor notified a home health agency wound specialist to help with dressing change in her home. As of (b)(6) 2021, she is still taking the antibiotics. However, the alleged injury is resolving. No allergies, medical history or intervention reported.
 
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Brand NameNEXCARE TEGADERM WATERPROOF TRANSPARENT 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
bryan becker
2510 conway avenue
st. paul, MN 55144
6517375578
MDR Report Key12583603
MDR Text Key274967493
Report Number2110898-2021-00062
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 Non-Healthcare Professional
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberH1626
Device Lot Number21193J
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2021
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: 10/06/2021 Patient Sequence Number: 1
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