BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 2992739 · Received March 7, 2013

    Report

    Report Number
    3005099803-2013-01153
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PROCEDURE USING AN UPHOLD LITE VAGINAL SUPPORT SYSTEM, AS THE LEG ASSEMBLY WAS BEING PLACED THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE DETACHED INSIDE THE PATIENT. REPORTEDLY, THE PHYSICIAN ATTEMPTED TO LOCATE THE NEEDLE BUT WAS UNABLE TO FIND IT. THE PHYSICIAN LEFT THE DETACHED NEEDLE INSIDE THE PATIENT AND COMPLETED THE PROCEDURE WITH THIS DEVICE, WITH NO COMPLICATIONS TO THE PATIENT, WHO WAS STABLE AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT IS BEING FOLLOWED AND HAS NOT EXPERIENCED ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96666 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170

    Patients

    Seq Age Sex Outcome Treatment
    1 Other