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 risks associated with water vapor thermal 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 was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Labeling review: the device instructions for use (ifu) was reviewed.The patient symptoms of urinary retention and urgency were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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It was reported that the patient underwent a water vapor thermal therapy procedure.The patient reported that the procedure was fine, and he had his catheter removed three days post procedure.He also states that his benign prostatic hyperplasia (bph) symptoms did not improve and are still present.He is urinating 5 to 6 times per night with difficulty when starting to urinate, it takes 5 to 10 minutes to start to urinate even though he is experiencing urgency.He is also experiencing urgency and frequent urination during the day along with some trickling of the urine stream.The patient met with his doctor on (b)(6) 2021; and treated with myrbetriq.
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