Model Number 2100V1 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn, Thermal (2530)
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Event Date 11/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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No new risks related to device performance were identified.
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Event Description
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This report pertains to one of three events that were received from the same site in the same timeframe.After uterine fibroid treatment the patient presented with severe skin burn.
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Manufacturer Narrative
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The clinical retrospective analysis does not represent new risks.The skin heating was identifiable in the real time thermal images.This was observed by the clinical team and a decision was made to continue despite the possible risk.After follow up visit, the site reported that the skin burn was healed without any complications.
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Event Description
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After uterine fibroid treatment the treating physician reported severe skin burns.In 2 weeks follow up, site reported that the wounds are healing and no signs for superinfection.In 2 months follow up, site reported that all skin burns healed without complications.
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Search Alerts/Recalls
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