Model Number 5100015270 |
Device Problem
Overheating of Device (1437)
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Patient Problems
Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
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Event Date 06/19/2019 |
Event Type
Injury
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Event Description
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The user facility reported the device overheated during a procedure, which lead to second and third degree burns incurred by the patient.Although requested, information regarding surgical delay, medical intervention, or if the procedure was completed successfully is unknown.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.
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Event Description
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The user facility reported the device overheated during a procedure, which lead to second and third degree burns incurred by the patient.Although requested, information regarding surgical delay, medical intervention, or if the procedure was completed successfully is unknown.
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Manufacturer Narrative
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Correction: this correction is being filed to update outcomes attributed to problem & adverse event.
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Event Description
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The user facility reported the device overheated during a procedure, which lead to second and third degree burns incurred by the patient.Although requested, information regarding surgical delay, medical intervention, or if the procedure was completed successfully is unknown.
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Search Alerts/Recalls
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