BARD CUNNIHGHAM MALE INCONTINENCE PENILE CLAMP

Description of Event or Problem

COMPLAINT # (B)(4). IT WAS REPORTED THAT THE PT WAS COMFORTABLE USING THE CLAMP INITIALLY. THE CLAMP IS ONLY USED FOR A COUPLE OF HOURS IN THE EVENING. AS USE OF THE CLAMP CONTINUED, THE PT DEVELOPED DISCOMFORT LEADING TO F/U VISITS WITH THE UROLOGIST. PT HAS BEEN CULTURED TWICE IN 10 DAYS, BOTH CAME BACK NEGATIVE FOR INFECTIONS. A SCOPE WAS DONE AND THE DOCTOR INFORMED THE PT THAT THERE IS A DARK SPORT ON THE URETHRA THAT APPEARS TO BE IN THE AREA WHERE THE CLAMP WOULD BE POSITIONED. PT UNDERWENT PROSTATE SURGERY IN (B)(6).

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL F/U REPORT WILL BE MAILED.