BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5112266 · Received September 29, 2015

    Report

    Report Number
    2183959-2015-00412
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 25, 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).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED AGAINST AN INITIAL REPORT THAT WAS SUBMITTED UNDER THE PREVIOUS SITE REGISTRATION NUMBER ((B)(4)). THE EFFECTIVE SITE REGISTRATION NUMBER IS (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT RECEIVED OXYCODONE FOR THE PAIN. THE EVENT WAS CONSIDERED RESOLVED/RECOVERED ON (B)(6) 2015 (NOT (B)(6) 2015 AS PREVIOUSLY REPORTED). NO FURTHER PATIENT COMPLICATIONS WERE REPORTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE ELEVATE ANTERIOR THE PATIENT EXPERIENCED MILD DE NOVO VAGINAL BLEEDING AND INTERMITTENT VAGINAL PAIN. NO INTERVENTION WAS TAKEN AND THE EVENTS WERE CONSIDERED RECOVERING/ RESOLVING (ADVERSE EVENT WAS IMPROVING). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT. RELATED TO MANUFACTURER REPORT #: 2183959-2015-00413.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PAIN AND VAGINAL BLEEDING WERE 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
    642983 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability