BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 2962426 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00908
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 21, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN UPHOLD LITE VAGINAL SUPPORT SYSTEM DURING AN ANTERIOR REPAIR PROCEDURE AROUND THE BEGINNING OF (B)(6) 2013. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT PER USUAL PROTOCOL. DURING THIS TIME, SHE HAD A SEVERE COUGHING EPISODE, WHICH CAUSED BOTH OF THE MESH LEGS TO PULL OUT OF THE SACROSPINOUS LIGAMENTS, ALTHOUGH THEY HAD REPORTEDLY BEEN IMPLANTED PROPERLY. AS A RESULT, THE PATIENT'S PROLAPSE RETURNED. CONSEQUENTLY, THE ENTIRE MESH DEVICE WAS EXPLANTED TWO WEEKS LATER. NO ADDITIONAL MEDICAL INTERVENTION IS PLANNED FOR THE PATIENT, WHO IS OVER 18 YEARS OF AGE AND IS REPORTEDLY IN OKAY CONDITION. THE PHYSICIAN DOES NOT BELIEVE THAT THE COUGHING EPISODE WAS RELATED TO THE UPHOLD DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65756 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention