Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Discomfort (2330)
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Event Date 03/15/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a water vapor therapy procedure.A few days post procedure the patient experienced some discomfort and noticed that the frequency to urinate had lessened.A few days after procedure, the patient went to the er and had the catheter removed as it was completely blocked.The patient noted that it was painful and began to feel the urge to frequently urinate.After a week, the patient had a follow-up with his physician for removal of the catheter.The patient stated that initially had feeling like was not completely emptying.
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Manufacturer Narrative
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Facility: (b)(4).Contact number: (b)(6).
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Manufacturer Narrative
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Facility: (b)(6).Physician: dr.(b)(6).Contact number: (b)(6).Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with a water vapor therapy procedure and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number and facility account number were not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the delivery device instructions for use (ifu) was reviewed.The patient symptoms of pain, discomfort, urinary retention and urinary frequency were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.
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Event Description
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It was reported that a patient underwent a water vapor therapy procedure.A few days post procedure the patient experienced some discomfort and noticed that the frequency to urinate had lessened.A few days after procedure, the patient went to the er and had the catheter removed as it was completely blocked.The patient noted that it was painful and began to feel the urge to frequently urinate.After a week, the patient had a follow-up with his physician for removal of the catheter.The patient stated that initially had feeling like was not completely emptying.
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Search Alerts/Recalls
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