Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Micturition Urgency (1871); Unspecified Infection (1930); Urinary Tract Infection (2120)
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Event Date 05/03/2019 |
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 that post a convective radiofrequency water vapor thermal therapy procedure the patient was experiencing a urinary tract infection and presented to the surgeon with a scrotal infection.The surgeon drained the hydrocele infection and washed the scrotal sac and closed.The patient was prescribed an extended course of antibiotics.Patient has good emptying of the bladder with some intermittent urgency.
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Manufacturer Narrative
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Date of event the exact date of the event was not reported the device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device was not returned so physical analysis could not be performed.A review of the instructions for use and operators manual did not reveal any evidence of device misuse, off-label use or failure to follow instructions.The adverse events reported are potential complications that may occur and therefore, the cause code of known inherent risk of device was applied to this event.
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Event Description
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It was reported that post a convective radiofrequency water vapor thermal therapy procedure the patient was experiencing a urinary tract infection and presented to the surgeon with a scrotal infection.The surgeon drained the hydrocele infection and washed the scrotal sac and closed.The patient was prescribed an extended course of antibiotics.Patient has good emptying of the bladder with some intermittent urgency.
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Search Alerts/Recalls
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