BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION TACK TRANSVAGINAL ANCHOR SYSTEM

    MDR report key: 275046 · Received April 26, 2000

    Report

    Report Number
    6000043-2000-00007
    Event Type
    Injury
    Date Received
    April 26, 2000
    Date of Event
    March 14, 2000
    Report Date
    April 26, 2000
    Manufacturer
    MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FHK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE WEEKS POST-OP, THE PT EXPERIENCED A BONE INFECTION AND THE BONE ANCHOR WAS REMOVED. THE PT RECEIVED IV ANTIBIOTICS FOR THE INFECTION. THE PT IS RECOVERING. THE PRODUCT WAS DESTROYED AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION TACK TRANSVAGINAL ANCHOR SYSTEM PERC STABILIZATION KIT FHK MICROVASIVE UROLOGY A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention