Model Number TT0.25F6-450 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problems
Partial thickness (Second Degree) Burn (2694); Swelling/ Edema (4577)
|
Event Date 11/04/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
The data logs were reviewed and the system and handpiece performed as expected.The user will want to verify proper treatment technique, position and orientation (with adequate coupling fluid and equal tip to skin contact and pressure).Cryogen appeared to be flowing during the treatment.Failure to maintain proper treatment technique results in unsafe conditions.The product has been requested.The investigation is underway.
|
|
Event Description
|
A patient reported a burn to their lower eyelid during a thermage flx treatment.Available pictures were reviewed by the medical reviewer.Crusted wounds are visible under one eye.The other eye reveals one crust as well.The current status is reported as lower eyelid oedema and secondary burn wounds.The patient stated that the treatment was very painful from the beginning of the procedure.The user facility reported that the patient was not administered any pain medication or placed under anesthesia.Secondary intervention was required to treat this event but there is no mention of what the intervention was.It is unknown if there will be any permanent damage or scarring.No other treatments (besides thermage) were being performed in the same area where the symptoms were reported.The patient has not undergone any other treatments in the same symptom area within the past 30 days.The highest energy level used was 3j.The return pad was disengaged and needed to be replaced.Solta medical cryogen and coupling fluid were used during this treatment.The treatment tip surface was not inspected prior to use nor during the procedure.
|
|
Manufacturer Narrative
|
As of the date of this report, the product has not been received for evaluation.According to thermage flx user manual, burns and swelling are a known possible side effect during a thermage flx treatment.The procedure produces heating in the upper layers of the skin and may cause burns and subsequent blister and scab formation.There is a small chance of scar formation.Application of topical steroidal or antibiotic preparations may be of benefit.In the rare instance of a burn that results in a scar, the scar will probably be very small and respond readily to removal with a laser device.A review of the manufacturing records showed all requirements were met.Final test verification specifications are acceptable.No non-conformities or anomalies found related to this complaint when reviewing the device history record.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, no causal factors can be determined, and no conclusions can be drawn.No corrective action is required.Should the product be returned and evaluated, a supplemental report will be filed.
|
|
Manufacturer Narrative
|
Correction: b3: date of event from 03-nov-2022 to 04-nov-2022.Correction: b5: describe event or problem: from "during a thermage flx treatment" to "the symptoms were noticed 1 day post thermage flx treatment." the treatment tip was returned and evaluated.Service was unable to verify any functional issue with the tip.The tip passed the leak and thermistor tests.The tip also passed visual inspection as no dents, scratches, blemishes or dielectric breakdown were observed.No functional test was able to be performed due to tip being expired.The system has software safeguards (such as a power on self-test) that will trigger error/event codes should system be outside of acceptable limits.The review of the system/data logs does not indicate there is any handpiece or system issue present.No issues found related to this event during evaluation of the tip.Based on the available information, this event is a known possible reaction to treatment.This complaint type is identified within risk analysis and performing within the anticipated rate.No corrective action is necessary at this time.
|
|
Event Description
|
The symptoms were noticed 1 day post thermage flx treatment.
|
|
Search Alerts/Recalls
|