BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5085423 · Received September 17, 2015

    Report

    Report Number
    2183959-2015-00397
    Event Type
    Injury
    Date Received
    September 17, 2015
    Date of Event
    September 11, 2015
    Report Date
    September 15, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE POSTERIOR, THE PATIENT EXPERIENCED A LOWER URINARY TRACT INFECTION AND DYSURIA. CIPRO WAS PRESCRIBED ON (B)(6) 2015. THE EVENT WAS CONSIDERED MODERATE AND NOT RECOVERED/NOT RESOLVED (CONTINUING). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615842 AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention