BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM

    MDR report key: 3083464 · Received April 29, 2013

    Report

    Report Number
    3005099803-2013-03258
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A SACROSPINOUS FIXATION PROCEDURE USING AN UPHOLD LITE VAGINAL SUPPORT SYSTEM, THE PHYSICIAN ACCIDENTALLY AND UNKNOWINGLY FIRED THE LEG ASSEMBLY INTO THE PATIENT'S BLADDER. WHEN HE PERFORMED A CYSTOSCOPY TO CHECK ON THE MESH POSITION, HE DISCOVERED THAT A SMALL PORTION OF THE MESH LEG HAD BEEN PULLED INTO THE BLADDER, SO HE SUBSEQUENTLY REMOVED THE UPHOLD DEVICE FROM THE PATIENT. NO MESH REMAINED INSIDE THE BLADDER. THE PHYSICIAN FELT THAT THE BLADDER PERFORATION WAS SMALL AND NON-INVASIVE. ADDITIONALLY, HE CONSULTED WITH ANOTHER UROLOGIST, WHO AGREED THAT THE PATIENT WOULD BE FINE WITHOUT ANY SORT OF REPAIR. THE PHYSICIAN DID NOT REPAIR THE PERFORATION AND COMPLETED THE PROCEDURE WITH A KELLY PLICATION. THERE WERE NO FURTHER COMPLICATIONS TO THE PATIENT, WHO WAS FINE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184518 PFR KIT ¿ UPHOLD LITE VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317170 ML00001342

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other