• 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 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 TRANSPARENT DRESSING TEGADERM¿ DRESSING Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Injury (2348)
Event Date 05/13/2020
Event Type  Injury  
Manufacturer Narrative
Weight, ethnicity & race: information was not provided. Health professional; occupation: 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, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products.
 
Event Description
The wife of a (b)(6)-year-old male consumer reported that she applied one of the larger-sized referenced dressings to cover a small cut on her husband's left forearm on approximately (b)(6) 2020. Prior to application, bacitracin was applied on the wound. The dressing was worn for five days. The dressing was removed on (b)(6) 2020. The wife alleged the dressing was very difficult to remove. The dressing was reportedly removed slowly while the wife held tight to her husband's skin. The wife alleged a layer of her husband's skin was ripped off during removal. The skin area reportedly bled. She alleged her hands were full of blood. The wife reported that her husband has thin skin. No known allergies or additional skin sensitivities were specified. A neighbor, rn by profession, applied a non-porous pad, 3" gauze and an elastic bandage on the skin area. The wife took her husband to urgent care to evaluate the area. The medical facility applied bacitracin on the wound and provided the husband with an unspecified antibiotic. The wife reported that her husband was taking the medication as prescribed and the skin area was healing.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNEXCARE TEGADERM TRANSPARENT DRESSING
Type of DeviceTEGADERM¿ DRESSING
Manufacturer (Section D)
3M HEALTH CARE
2510 conway ave
st. paul, mn
Manufacturer (Section G)
3M COMPANY
601 22nd ave south
brookings, sd
Manufacturer Contact
bryan becker
2510 conway avenue
st. paul, mn 
7375578
MDR Report Key10162803
MDR Text Key195705586
Report Number2110898-2020-00032
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
Type of Report Initial
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date07/05/2022
Device Model NumberN/A
Device Catalogue NumberTEGA-10
Device Lot Number19283J
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2019
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: 06/17/2020 Patient Sequence Number: 1
-
-