BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD

    MDR report key: 2479479 · Received March 2, 2012

    Report

    Report Number
    MW5024484
    Event Type
    Injury
    Date Received
    March 2, 2012
    Date of Event
    June 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR HAD DEVICES IMPLANTED BECAUSE OF URINARY INCONTINENCE. THE MESH HAS NOW BEEN EXPOSED AND SHE IS FACING SURGERY. SHE IS TAKING ANTIBIOTICS (DOXYCYCLINE AND FLUCONAZOLE) AND SERTRALINE 50 MG FOR ANXIETY. SHE IS ANXIOUS ALL THE TIME AND HAVING TROUBLE SLEEPING. PATIENT FELT GOOD FOR ABOUT A MONTH AND THEN STARTING HAVING RUNNING STOOLS WITH VOIDING. SHE HAD PROBLEMS VOIDING AND EMPTYING HER BLADDER AND HAD AN INDWELLING CATHETER FOR TWO MONTHS. SHE STARTED LEAKING AGAIN, SAW HER AYN AND FOUND THE EXTRUDING MESH. SHE NOW IS FACING ANOTHER SURGERY AND REFUSES TO HAVE THESE DEVICES IN HER BODY. SHE CAN NO LONGER HAVE SEX BECAUSE OF PAIN AND IF IS NOT CONSTIPATED, SHE HAS DIARRHEA.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR: (B)(6) 2012: THE MESH IS COMING THROUGH THE VAGINA AS IS URINE. RPTR IS ALSO EXPERIENCING GAS. SHE CANNOT HAVE SURGERY THROUGH THE BELLY BUTTON AND DOESN'T KNOW WHAT CAN BE DONE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR (B)(6) 2012: PT HAS HER MEDICAL RECORDS WHICH DESCRIBES HER (B)(6) 2010 PROCEDURE, AS A LAPAROSCOPIC ASSISTED VAGINAL SALPINGO-OOPHORECTOMY, SLING, CYSTOSCOPY, ANTERIOR/POSTERIOR COMPARTMENT RECONSTRUCTION AND VAGINAL VAULT SUSPENSION. ON (B)(6) 2012, SHE SAW THE GYN FOR PAP SMEAR AND FOUND SHE HAS A HOLE IN THE VAGINA. SHE NOW VOIDS THROUGH HER VAGINA. HER NEXT SURGERY IS SCHEDULED FOR (B)(6) 2012: EXPLORATORY SURGERY TO SEE WHAT MUST BE DONE AND THEN WILL HAVE TO RETURN FOR REPAIR. SHE REMAINS UNCOMFORTABLE, UNABLE TO HAVE GET BECAUSE OF THE PAIN, HAS LOTS OF GAS AND STILL FULL OF ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD MESH FTL BOSTON SCIENTIFIC 1ML0031502
    2 XEN FORM MESH FTL BOSTON SCIENTIFIC 1003011
    3 COLOPLAST SUPRIS SUPRABUBIC SLING MESH OTN COLOPLAST 1919200
    4 COOK UROLOGICAL STRATASIS URETHRAL SLING FTL COOK LB 436207
    5 COOK UROLOGICAL SOFT TISSUE GRAFT SOFT TISSUE GRAFT FTL COOK LB411655

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention| S