Model Number TT3.00F6-900 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Burn(s) (1757); Inflammation (1932); Blister (4537)
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Event Date 01/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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The tip has been requested but not yet received.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
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Event Description
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A distributor reported that a patient experienced burns and blisters on the left side of the face after a thermage treatment.The patient was given an unknown topical anesthetic prior to treatment.Post ¿ treatment the patient was treated with burn ointment and an unknown skin care product that promotes healing.It is unknown whether there will be any permanent scarring.Available photos were reviewed.Inflammation is visible on the patient''s cheek and show large blisters at the site of inflammation.The tip was inspected before treatment and every 50-80 pulses during treatment, nothing unusual was noted.The highest energy level used was 4 and enough cryogen fluid was used.During treatment, an error message of ¿tip can''t be recognized¿ was observed.
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Manufacturer Narrative
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The tip was returned and evaluated.Tip passed thermistor testing, leak test, and visual inspection.No functional test was performed due to the tip being expired.The review of the system/data logs does not indicate there is any handpiece or system issue present.A review of the device history records is in progress.Based on all available information, no causal factors can be determined and no conclusion can be drawn.
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Manufacturer Narrative
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Evaluation of the treatment tip found no issues related to this event.Tip passed incoming leak, visual, and thermistor tests.No dents, scratches, blemishes, or dielectric breakdown observed.A review of the manufacturing records showed all requirements were met.Datalogs confirmed the system and handpiece performed as expected.Evaluation of the treatment tip found no issues.Based on the available information, blisters are a known possible side effect during a thermage flx treatment.
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Search Alerts/Recalls
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