BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5086941 · Received September 18, 2015

    Report

    Report Number
    2183959-2015-00400
    Event Type
    Injury
    Date Received
    September 18, 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)

    Additional Manufacturer Narrative · 1

    ADD'L INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANT OF AN ELEVATE POSTERIOR. THE PATIENT EXPERIENCED MILD RECTAL PAIN AND PAINFUL BOWEL MOVEMENTS. OXYCODONE WAS PRESCRIBED AND THE EVENT WAS CONSIDERED NOT RECOVERING/ NOT RESOLVED (CONTINUING). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RECTAL PAIN WAS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE ON (B)(6) 2015. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618323 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