BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    MDR report key: 4882740 · Received July 1, 2015

    Report

    Report Number
    2183959-2015-00286
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    November 2, 2015
    Report Date
    June 26, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT DESPITE THE PREVIOUS MESH REVISION MORE MESH WAS FOUND TO BE EXPOSED ON (B)(6) 2015. THE PATIENT WILL BE SCHEDULED FOR FURTHER MESH REVISION AND THE EVENT WAS CONSIDERED NOT RECOVERED/NOT RESOLVING (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 EVENT WAS CONSIDERED RESOLVED/RECOVERED WITH NO SEQUELAE AS OF 08/18/2015. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS "OPERATED ON AND THE EXPOSED MESH WAS TRIMMED". IT WAS ALSO REPORTED THAT THE PATIENT WAS DISCHARGED THE SAME DAY. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF AN ELEVATE ANTERIOR GRAFT, THE PATIENT EXPERIENCED MODERATE MESH EXPOSURE IN THE VAGINA. TOPICAL MEDICATION WAS ADMINISTERED ON (B)(6) 2015. THE EVENT IS CONSIDERED NOT RECOVERED/NOT RESOLVED (CONTINUING). THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE TOPICAL MEDICATION "DID NOT HELP." IT WAS ALSO REPORTED THAT THE PATIENT IS SCHEDULED "FOR A MESH REPAIR". THE EVENT IS CONSIDERED NOT RECOVERED/NOT RESOLVED (CONTINUING) AS OF (B)(6) 2015. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426702 AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE SURGICAL MESH OTP ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VAGINAL HYSTERECTOMY