Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 06/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: the exact date of the event was not reported.
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Event Description
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It was reported by a patients friend via social media that the friend had under gone a convective radiofrequency water vapor thermal therapy procedure and was in and out of the hospital for three months with internal bleeding.Not further information was provided.
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Event Description
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It was reported by a patients friend via social media that the friend had under gone a convective radiofrequency water vapor thermal therapy procedure and was in and out of the hospital for three months with internal bleeding.Not further information was provided.
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Manufacturer Narrative
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Date of event the exact date of the event was not reported the device is not available for analysis.A review of the rezum ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on review of the information available, hemorrhage is known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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Search Alerts/Recalls
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