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U.S. Department of Health and Human Services

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

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3M COMPANY/3M HEALTHCARE TEGADERM DRESSING WOUND OCCLUSIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Swelling (2091)
Event Type  Injury  
Event Description
Severe reaction to tegaderm wound dressing following surgery. Area under and at the boundary of the dressing developed severe inflammation and large blistering similar to a chemical burn. Skin is still recovering almost two weeks following initial application of dressing.
 
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Brand NameTEGADERM
Type of DeviceDRESSING WOUND OCCLUSIVE
Manufacturer (Section D)
3M COMPANY/3M HEALTHCARE
MDR Report Key7768572
MDR Text Key116856475
Report NumberMW5078960
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 08/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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?
Type of Device Usage

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