• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

3M HEALTH CARE NEXCARE TEGADERM WATERPROOF TRANSPARENT DRESSING TEGADERM¿ DRESSING Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Erythema (1840); Rash (2033); Skin Inflammation/ Irritation (4545)
Event Date 09/28/2020
Event Type  Injury  
Manufacturer Narrative
Lot number was not reported. No sample has been received for analysis and no lot number was provided. 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.
 
Event Description
A (b)(6) years old female customer alleged a nexcare¿ tegaderm¿ waterproof transparent dressing caused puss, a nasty rash, bleeding and scabbing to both of her breast. Customer reported she had a double mastectomy with immediate reconstruction on (b)(6) 2020. The referenced dressing was used on the surgical wound. Customer stated the reaction was so 'terrible' the doctor told her to take off the dressing after reviewing pictures sent of the affected area. The dressing was removed on (b)(6) 2020. Customer alleged it felt like she was waxing a wound when the dressing was removed. The customer alleged that during removal of the dressing, parts of her skin was ripped. The existing incision reportedly bled. The rash allegedly oozed, then scabbed over. The customer alleged her skin, over each breast, was red. The customer was reportedly prescribed antibiotics by her plastic surgeon to treat the area. She also applied an unspecified tropical ointment to the area. The customer reported that she is continuing with prescribed treatment. The rash is reportedly still present.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10815576
MDR Text Key215471082
Report Number2110898-2020-00054
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 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue NumberH1624
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2020
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: 11/10/2020 Patient Sequence Number: 1
-
-