BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 3673363 · Received March 11, 2014

    Report

    Report Number
    2183959-2014-00067
    Event Type
    Injury
    Date Received
    March 11, 2014
    Date of Event
    December 1, 2013
    Report Date
    February 19, 2014
    Manufacturer
    ASTORA WOMEN'S HEALTH (IRELAND)
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW, IT HAS BEEN CONFIRMED THAT THIS DEVICE WAS MANUFACTURED AT AMERICAN MEDICAL SYSTEMS IN (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 (2183959). THE EFFECTIVE SITE REGISTRATION NUMBER IS 3011770902.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT WAS RESOLVED ON (B)(6) 2015. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COMPLAINED OF INCONTINENCE. IT WAS NOTED THE PATIENT NOW HAS OVER ACTIVE BLADDER SYMPTOMS THAT ARE WORSE THAN BASELINE AND SOME URGENCY THAT'S UNCONTROLLED. THE MESH REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THE ONSET DATE OF EVENT WAS (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144875 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH (IRELAND)

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability