Model Number CR-10-P |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Superficial (First Degree) Burn (2685)
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Event Date 09/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model: cr-10-p; serial/lot: (b)(4); description: injection electrode: 10cm, 5mm tip.The devices were not returned to bsn as they were discarded by the medical facility.
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Event Description
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A report was received that the patient developed two welts or bumps on the skin where the needles had been placed.The physician believed it was a burn but did not do diagnostic checks to confirm.There was no intervention to treat the burn.
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Event Description
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A report was received that the patient underwent a radiofrequency degeneration procedure.The patient developed two welts or bumps on the skin where the needles had been placed.The physician believed it was a burn but did not do diagnostic checks to confirm.There was no intervention to treat the burn.
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model: cr-10-p, serial/lot: (b)(4), description: injection electrode: 10cm, 5mm tip.The devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
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Search Alerts/Recalls
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