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

MAUDE Adverse Event Report: THERMIGEN LLC THERMIVA SYMPHONY RF GENERAL

  • 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
 

THERMIGEN LLC THERMIVA SYMPHONY RF GENERAL Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 05/15/2018
Event Type  Injury  
Event Description
Chronic pain after having thermiva treatment completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTHERMIVA
Type of DeviceSYMPHONY RF GENERAL
Manufacturer (Section D)
THERMIGEN LLC
MDR Report Key7742636
MDR Text Key115977322
Report NumberMW5078784
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 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2018
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

-
-