Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Retention (2119)
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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 that the patient stated that the water vapor therapy did not improve his symptoms post procedure and is still experiencing urinary retention.The patient underwent a transurethral resection of the prostate (turp) on january, 2022.
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Manufacturer Narrative
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Date of event: the exact event date is unknown.
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Manufacturer Narrative
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B3 date of event: the exact event date is unknown.H6 impact code updated: there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptom is a known risk associated with water vapor therapy, as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient stated that the water vapor therapy did not improve his symptoms post procedure and is still experiencing urinary retention.The patient underwent a transurethral resection of the prostate (turp) on (b)(6) 2022.
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Search Alerts/Recalls
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