• 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 3M TEGADERM TRANSPARENT FILM DRESSING TEGADERM¿ TRANSPARENT FILM 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 3M TEGADERM TRANSPARENT FILM DRESSING TEGADERM¿ TRANSPARENT FILM DRESSING Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Reaction (2414); Skin Inflammation (2443)
Event Date 04/04/2018
Event Type  Injury  
Manufacturer Narrative
Weight: information was not provided. Initial reporter: email address was not provided. End of report.
 
Event Description
A consumer alleged she experienced a bright red rash, itching, bruising, pain, swelling and elevated liver enzymes following use of a 1624w 3m¿ tegaderm¿ transparent film dressing. The dressing was used to secure a gauze sponge over an abdominal incision following surgery for a cyst removal. The reaction reportedly progressed and spread beyond the area where the dressing was applied. She saw her physician and was treated with a topical prescription for mometasone cream. She also reportedly used otc antihistamines for treatment. She reported the reaction was slowly resolving but the skin was still tender.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3M TEGADERM TRANSPARENT FILM DRESSING
Type of DeviceTEGADERM¿ TRANSPARENT FILM 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
brendan casey, ph.d.
275 5w-06
st. paul, MN 55144
6517374488
MDR Report Key7436209
MDR Text Key105672794
Report Number2110898-2018-00042
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 Patient
Type of Report Initial
Report Date 04/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberN/A
Device Catalogue Number1624W
Device Lot Number2018-06-PD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2015
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: 04/17/2018 Patient Sequence Number: 1
-
-