Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Patient Problem/Medical Problem (2688)
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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: actual event date is unknown.
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Event Description
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A patient reported via social media that post convective radiofrequency water vapor thermal therapy procedure, is experiencing frequent urinary urges and lost of bladder function at night.The patient still needs to take medication to address benign prostatic hyperplasia (bph) symptoms, which was the reason for having the procedure.
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Manufacturer Narrative
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Date of event: actual event date is unknown.Patient code 2688 patient problem/medical problem corrected to 1928 incontinence based on b5 describe event or problem section.
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Event Description
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A patient reported via social media that post convective radiofrequency water vapor thermal therapy procedure, is experiencing frequent urinary urges and lost of bladder function at night.The patient still needs to take medication to address benign prostatic hyperplasia (bph) symptoms, which was the reason for having the procedure.
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Event Description
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A patient reported via social media that post convective radiofrequency water vapor thermal therapy procedure, is experiencing frequent urinary urges and lost of bladder function at night.The patient still needs to take medication to address benign prostatic hyperplasia (bph) symptoms, which was the reason for having the procedure.
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Manufacturer Narrative
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B3.Date of event: actual event date is unknown.The product was not returned so no physical analysis could be performed.A labeling review was performed, urinary urgency and urinary incontinence are documented as a potential risks associated with the use of the device.There was no evidence that the device was used or handled improperly.Based on the information available, an evaluation conclusion code of known inherent risk of device was assigned to this investigation.
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Search Alerts/Recalls
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