BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 3070929 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-03035
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN APICAL PROLAPSE REPAIR PROCEDURE USING AN UPHOLD LITE VAGINAL SUPPORT SYSTEM, AS THE PHYSICIAN WAS PULLING ONE OF THE LEG ASSEMBLIES THROUGH THE PATIENT'S LIGAMENT, THE LEG DETACHED. IT IS UNKNOWN WHETHER THE DETACHED LEG ASSEMBLY FELL INTO THE PATIENT. THE ACCOUNT REMOVED THE DEVICE FROM WITHIN THE PATIENT AND FROM SERVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD LITE VAGINAL SUPPORT SYSTEM. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO IS OVER 18 YEARS OF AGE AND WAS FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172750 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170 ML00001205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other