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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THERMIGEN, LLC THERMIVA ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES

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THERMIGEN, LLC THERMIVA ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Pain (1994); Burning Sensation (2146); No Code Available (3191)
Event Date 10/01/2017
Event Type  Injury  
Event Description
I had the thermiva on my second treatment; about two months later, i started having burning, dryness, pain during sex. Went back to dr and told him about the problem, he gave me some cream to use.
 
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Brand NameTHERMIVA
Type of DeviceELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
Manufacturer (Section D)
THERMIGEN, LLC
MDR Report Key8274086
MDR Text Key134184001
Report NumberMW5083340
Device Sequence Number1
Product Code GEI
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 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
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

Patient Treatment Data
Date Received: 01/23/2019 Patient Sequence Number: 1
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