BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5208057 · Received November 6, 2015

    Report

    Report Number
    3011770902-2015-00014
    Event Type
    Injury
    Date Received
    November 6, 2015
    Date of Event
    October 14, 2015
    Report Date
    November 4, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT WAS NOT RESOLVED. THE PATIENT CONTINUED TO LEAK, BUT ONLY WHEN OUTSIDE OF HER HOUSE. AN "AZO" CHALLENGE WAS POSITIVE. A PVR (POST VOID RESIDUAL) WAS 167CC ON (B)(6) 2016; THE PATIENT WAS STARTED ON FLOMAX .4 MG THAT SAME DAY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE EVENT RESOLVED/RECOVERED WITH NO SEQUELAE ON (B)(6) 2015. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE POSTERIOR THE PATIENT EXPERIENCED STRESS URINARY INCONTINENCE (SUI). THE PATIENT WAS LEAKING WHEN WALKING AND BENDING; OXYBUTYNIN WAS PRESCRIBED ON (B)(6) 2015. THE PATIENT CONTINUED TO HAVE SUI WITH WALKING AND BENDING AND WAS THEN PRESCRIBED MYRBETRIQ DUE TO SIDE EFFECTS FROM OXYBUTYNIN ON (B)(6) 2015. URODYNAMICS WERE SCHEDULED FOR (B)(6) 2015 AND THE EVENT WAS CONSIDERED NOT RECOVERED/NOT RESOLVED (CONTINUING). NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737658 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability