BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4921753 · Received July 17, 2015

    Report

    Report Number
    2183959-2015-00318
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    October 3, 2014
    Report Date
    July 10, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE ANTERIOR THE PATIENT EXPERIENCED MILD LOWER BACK PAIN. NO INTERVENTION HAS BEEN DONE AND THE EVENT IS CONSIDERED 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 PATIENT EXPERIENCED DISCOMFORT. AS OF (B)(6) 2016, THE EVENT WAS STILL CONSIDERED CONTINUING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465984 AMS ELEVATE PC ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability