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

MAUDE Adverse Event Report: 3M COMPANY TEGADERM DRESSING, WOUND, OCCLUSIVE

  • 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 COMPANY TEGADERM DRESSING, WOUND, OCCLUSIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Urticaria (2278)
Event Date 05/05/2019
Event Type  Injury  
Event Description
Allergic reaction to tegaderm bandage applied following abdominal surgery. Laparoscopic surgery performed on (b)(6) 2019. Three tegaderm bandage 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. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTEGADERM
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
3M COMPANY
MDR Report Key8599908
MDR Text Key144860098
Report NumberMW5086526
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/07/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/09/2019 Patient Sequence Number: 1
-
-