BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    MDR report key: 8080412 · Received November 16, 2018

    Report

    Report Number
    3003477176-2018-00026
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 25, 2018
    Report Date
    March 13, 2019
    Manufacturer
    UROMEDICA, INC
    Product Code
    EZY
    UDI-DI
    00180668000380
    PMA / PMN Number
    P130018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UNIT COULD NOT BE RETRIEVED FROM UNIVERSITY OF FLORIDA HEALTH PATHOLOGY, DESPITE SEVERAL ATTEMPTS BY UROMEDICA SALES STAFF. THIS UPDATE, FOLLOW-UP #2, IS LINKED TO A 14 FEB 2019 WRITTEN REQUEST BY (B)(6), MD OF CDRH FOR ADDITIONAL INFORMATION RELATED TO THIS EVENT. WHILE EVALUATING ANSWERING DR. (B)(6) QUESTIONS, UROMEDICA CORRESPONDED FURTHER WITH THE IMPLANTING PHYSICIAN AND IS ADJUSTING THE SECTION H EVENT PROBLEM AND EVALUATION CODES ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    UNIT COULD NOT BE RETRIEVED FROM (B)(6), DESPITE ATTEMPTS BY UROMEDICA SALES STAFF.

    Description of Event or Problem · 0

    DUAL RECTAL PERFORATION DURING PROACT ADJUSTABLE CONTINENCE THERAPY IMPLANT PROCEDURE. IMMEDIATELY FOLLOWING THE PROACT IMPLANT PROCEDURE, THE PATIENT HAD A BOWEL MOVEMENT AND THE LEFT BALLOON WAS COMING OUT OF THE RECTUM. THE UROLOGIST PREFERRED TO TREAT THE PATIENT WITH TEMPORARY COLOSTOMY UNTIL THE RECTAL PERFORATION HEALS. COLORECTAL SURGEONS BELIEVE THAT THE PATIENT MAY BENEFIT FROM A PERMANENT COLOSTOMY DUE TO PREVIOUS AND ONGOING FECAL INCONTINENCE. COLOSTOMY PERFORMED. THE UROLOGIST EXPLANTED BOTH BALLOONS THROUGH THE RECTAL WALL. THE RIGHT BALLOON WAS PUNCTURED BY NEEDLE (INTENTIONALLY), DEFLATED, AND PULLED OUT BY TUBING THROUGH THE RECTAL DEFECT. THE LEFT BALLOON WAS PULLED OUT OF THE RECTUM BY THE BALLOON.

    Description of Event or Problem · 0

    DUAL RECTAL PERFORATION DURING PROACT ADJUSTABLE CONTINENCE THERAPY IMPLANT PROCEDURE. IMMEDIATELY FOLLOWING THE PROACT IMPLANT PROCEDURE, THE PATIENT HAD A BOWEL MOVEMENT AND THE LEFT BALLOON WAS COMING OUT OF THE RECTUM. THE UROLOGIST PREFERRED TO TREAT THE PATIENT WITH TEMPORARY COLOSTOMY UNTIL THE RECTAL PERFORATION HEALS. COLORECTAL SURGEONS BELIEVE THAT THE PATIENT MAY BENEFIT FROM A PERMANENT COLOSTOMY DUE TO PREVIOUS AND ONGOING FECAL INCONTINENCE. COLOSTOMY PERFORMED. THE UROLOGIST EXPLANTED BOTH BALLOONS THROUGH THE RECTAL WALL. THE RIGHT BALLOON WAS PUNCTURED BY NEEDLE (INTENTIONALLY), DEFLATED, AND PULLED OUT BY TUBING THROUGH THE RECTAL DEFECT. THE LEFT BALLOON WAS PULLED OUT OF THE RECTUM BY THE BALLOON.

    Description of Event or Problem · 1

    DUAL RECTAL PERFORATION DURING PROACT ADJUSTABLE CONTINENCE THERAPY IMPLANT PROCEDURE. IMMEDIATELY FOLLOWING THE PROACT IMPLANT PROCEDURE, THE PATIENT HAD A BOWEL MOVEMENT AND THE LEFT BALLOON WAS COMING OUT OF THE RECTUM. THE UROLOGIST PREFERRED TO TREAT THE PATIENT WITH TEMPORARY COLOSTOMY UNTIL THE RECTAL PERFORATION HEALS. COLORECTAL SURGEONS BELIEVE THAT THE PATIENT MAY BENEFIT FROM A PERMANENT COLOSTOMY DUE TO PREVIOUS AND ONGOING FECAL INCONTINENCE. COLOSTOMY PERFORMED. THE UROLOGIST EXPLANTED BOTH BALLOONS THROUGH THE RECTAL WALL. THE RIGHT BALLOON WAS PUNCTURED BY NEEDLE (INTENTIONALLY), DEFLATED, AND PULLED OUT BY TUBING THROUGH THE RECTAL DEFECT. THE LEFT BALLOON WAS PULLED OUT OF THE RECTUM BY THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920834 PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN PROACT EZY UROMEDICA, INC 800018-14 UM00598 00180668000380

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R