BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800

    MDR report key: 7637867 · Received June 25, 2018

    Report

    Report Number
    MW5078057
    Event Type
    Injury
    Date Received
    June 25, 2018
    Date of Event
    February 1, 2018
    Report Date
    June 22, 2018
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, I HAD AN AMERICAN MEDICAL SYSTEMS, INC., AMS 800 URINARY SPHINCTER DEVICE INSTALLED BY DR (B)(6) WHO IS A UROLOGIST SURGEON FROM (B)(6) MEDICAL GROUP. THE DEVICE FAILED TO DO WHAT WAS EXPECTED IN THE MIDDLE OF 2016. I SAW DR (B)(6) WHO DID THE SURGERY AND AFTER DOING A CYSTOSCOPE, HE REALIZED IT WAS NOT WORKING AS EXPECTED AND STATED HE HAS TO REDO THE SURGERY TO ADD ANOTHER CUFF TO ELIMINATE THE LEAKAGE. CORRECTIVE SURGERY WAS DONE ON (B)(6) 2016. I ASKED DR (B)(6) TO SAVE ME THE DEVICE THAT HE IS CORRECTING, BUT HE JUST GAVE ME A CUFF AND NOTHING ELSE WHICH I STILL HAVE IN MY POSSESSION. STARTED HAVING ISSUES AGAIN IN (B)(6) 2017 WITH LEAKAGE. LEAKAGE BECAME WORSE AND APPT WAS MADE WITH DR (B)(6) AND HE SCHEDULED A CYSTOSCOPE TO SEE WHAT WAS GOING ON. AFTER DOING THE CYSTOSCOPE HE INFORMED ME THAT THE CUFF WAS WIDE OPEN WHEN IT SHOULD HAVE BEEN CLOSED AND SUGGESTED THAT ANOTHER SURGERY WOULD BE REQUIRED TO INSTALL A NEW DEVICE AGAIN. AFTER 2 FAILURES OF THE DEVICE, I INFORMED DR (B)(6) DOING A THIRD ONE DOES NOT MAKE SENSE SINCE THE PRODUCT IS DEFECTIVE AND DOES NOT WORK AS STATED. UPON CHECKING FDA SYSTEM IT SHOWED THAT THE AMS 800 HAD RECALLS FROM THE FDA FOR MFG ISSUES AND I WONDER IF THESE PRODUCTS THAT WERE RECALLED WERE JUST REPACKAGED AND PLACED BACK ON THE MARKET. CHECKING WITH (B)(6) HOSPITAL IN (B)(6) WHERE THE SURGERY OCCURRED, THEIR RECORD SHOWED THAT ON BOTH SURGERIES THERE WAS A REP FROM AMERICAN MEDICAL SYSTEMS IN THE SURGERY ROOM ALSO. AFTER DOING SOME RESEARCH I FOUND OUT THAT THERE WAS A MALE SLING DEVICE THAT COULD HAVE CORRECTED THE LEAKAGE AFTER MY PROSTATE SURGERY. I ASKED DR (B)(6) ABOUT INSTALLING THE SLING AND HE REPLIED HE ONLY DOES THE AMS SYSTEM. I WONDER WHY DOES THE DR RECEIVE COMPENSATION FROM AMERICAN MEDICAL SYSTEMS, INC., TO USE THEIR PRODUCT SINCE HE WANTED TO DO A THIRD ONE. WELL NOW SINCE THE DR DOES NOT DO THAT SURGERY I AM BEING SENT TO (B)(6) HOSPITAL IN (B)(6) TO SEE A SPECIALIST IN UROLOGY SURGERY. IF I AM HAVING ISSUES WITH THE DEVICE, HOW MANY OTHERS ARE SUFFERING AS I AM WITH THE DEFECTIVE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475133 AMS 800 DEVICE, INCONTIENCE, MECHANICAL HYDRAULIC EZY AMERICAN MEDICAL SYSTEMS, INC.
    475134 AMS 800 DEVICE, INCONTIENCE, MECHANICAL HYDRAULIC EZY AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention