Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Insufficient Information (4580)
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Event Date 01/01/2022 |
Event Type
Injury
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Event Description
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It was reported by the patient via social media that the rezum water vapor therapy procedure did not work and urinary urgency symptom is the same as prior to the procedure.The patient also indicated of now having a distorted urinary stream.The patient has had to double his flomax (unknown dose) medication to two times a day.No further information was provided.
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Event Description
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It was reported by the patient via social media that the rezum water vapor therapy procedure did not work for him that his urinary urgency remains the same as prior to the procedure.The patient also indicated he now has a distorted urinary stream.The patient reported that he has had to double his current dose (amount unknown) of flomax and is now taking it twice daily.
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Manufacturer Narrative
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The delivery device was not returned for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom of urinary urgency is a known risk associated with water vapor therapy procedures and is noted as such in the device instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Search Alerts/Recalls
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