There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms of urinary incontinence, urinary frequency, urinary retention and urinary urgency are known risks associated with the use of this device 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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