Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Complaint, Ill-Defined (2331); Hematuria (2558); Patient Problem/Medical Problem (2688)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that patient had convective radiofrequency water vapor thermal therapy procedure done a year ago.Patient states he experienced urinating blood two and a half to three months after procedure took place.He noticed that the effects of the procedure lasted seven months.
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Manufacturer Narrative
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H6.Patient code 2688 is being used for the ineffective treatment the device is not available for analysis.A review of the 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, hematuria and patient problem/medical problem are known risks associated with the use of the device and are noted as such in the instructions for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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Event Description
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It was reported that patient had convective radiofrequency water vapor thermal therapy procedure done a year ago.Patient states he experienced urinating blood two and a half to three months after procedure took place.He noticed that the effects of the procedure lasted seven months.
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Search Alerts/Recalls
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