BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS RETROARC RETROPUBIC SLING SYSTEM

    MDR report key: 5112268 · Received September 29, 2015

    Report

    Report Number
    2183959-2015-00413
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 22, 2015
    Report Date
    September 25, 2015
    Manufacturer
    ASTORA WOMEN'S HEALTH LLC
    Product Code
    OTN
    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

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PATIENT RECEIVED OXYCODONE FOR THE PAIN. THE EVENT WAS CONSIDERED RESOLVED/RECOVERED ON (B)(6) 2015 (NOT (B)(6) 2015 AS PREVIOUSLY REPORTED). NO FURTHER PATIENT COMPLICATIONS WERE REPORTED RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF A RETROARC THE PATIENT EXPERIENCED MILD DE NOVO VAGINAL BLEEDING AND INTERMITTENT VAGINAL PAIN. NO INTERVENTION WAS TAKEN AND THE EVENTS WERE CONSIDERED RECOVERING/ RESOLVING (ADVERSE EVENT WAS IMPROVING). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT. RELATED TO MANUFACTURER REPORT #: 2183959-2015-00412.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE PAIN AND VAGINAL BLEEDING WERE 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
    641349 AMS RETROARC RETROPUBIC SLING SYSTEM MESH, SURGICAL, POLYMERIC OTN ASTORA WOMEN'S HEALTH LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability NATIVE TISSUE RECTOCELE REPAIR