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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOLTA MEDICAL, INC THERMAGE CPT ELECTROSURGICAL UNIT AND ACCESSORIES

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SOLTA MEDICAL, INC THERMAGE CPT ELECTROSURGICAL UNIT AND ACCESSORIES Back to Search Results
Model Number CPT
Event Date 07/20/2011
Event Type  Injury  
Event Description

On (b)(6) 2011, solta medical was notified of a patient who received burns following a thermage treatment when a single-use treatment tip was re-used. Per the event information gathering form, it was unknown if a serious injury occurred when initially reported. Two follow-up e-mails were sent by solta medical to get information on the status of the patient. On (b)(6) 2011, a response was received that some of the injuries resulted in scars and reportability was determined.

 
Manufacturer Narrative

The device treatment tip was returned to solta for analysis. A dielectric breakdown of the tip membrane was found. Per the thermage cpt system technical user's manual, "inspect the treatment tips for any signs of physical damage prior to treatment. If any physical damage is found, do not use the damaged tip and replace before initiating treatment". A technical bulletin (tb-19) had been previously released informing customers to apply sufficient amount of coupling fluid to patient's skin and also frequently inspect treatment tips during treatment for any signs of tip breakdown. Information in the initial report of the adverse event stated that one treatment tip was used for 2 patients (the first patient had no injury). Per the thermage cpt system technical user's manual, "the thermage treatment tips are single-use only and designed for single patient use and single-use only and must not be reused".

 
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Brand NameTHERMAGE CPT
Type of DeviceELECTROSURGICAL UNIT AND ACCESSORIES
Manufacturer (Section D)
SOLTA MEDICAL, INC
25881 industrial blvd.
hayward CA 94545
Manufacturer Contact
kristi guest
25881 industrial blvd.
hayward , CA 94545
5107822286
MDR Report Key2298057
Report Number2954746-2011-00013
Device Sequence Number1
Product CodeGEI
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/23/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/12/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL NumberCPT
Device Catalogue NumberTG-2B-UPG
Device LOT NumberM30066
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer08/01/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/23/2011
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/12/2011 Patient Sequence Number: 1
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