BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 5000214 · Received August 13, 2015

    Report

    Report Number
    2183959-2015-00354
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 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 IMPLANT OF AN ELEVATE ANTERIOR THE PATIENT EXPERIENCED ABDOMINAL AND VAGINAL PAIN. IT WAS STATED "PT COMPLAINED OF OCCASIONAL SHARP VAGINAL PAIN" AND "HAS OCCASIONAL SHARP ABDOMINAL PAIN THAT RESOLVES QUICKLY WITHOUT MEDICATION." IT WAS ALSO NOTED THAT "PATIENT DID NOT NOTE THIS ON THE PAIN PORTION OF THE QUESTIONNAIRE." 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 INDICATING THAT THE ABDOMINAL AND VAGINAL PAIN 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
    533872 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