BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAERVELDT GLAUCOMA IMPLANT

    MDR report key: 215374 · Received March 17, 1999

    Report

    Report Number
    9614546-1999-00006
    Event Type
    Malfunction
    Date Received
    March 17, 1999
    Date of Event
    January 1, 1999
    Report Date
    March 17, 1999
    Manufacturer
    PHARMACIA BV PRODUCTION
    Product Code
    KYF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PURCHASING MANAGER REPORTED THAT A PHYSICIAN DISCOVERED THE ARM (DRAINAGE TUBE) WAS BROKEN OFF A BAERVELDT SHUNT, MODEL BG-101-350 WHEN THE PACKAGE WAS FIRST OPENED. THERE WAS NO PT CONTACT AND THE PHYSICIAN SIMPLY USED A BACKUP SHUNT. THEY SPECULATED THAT THE SHUNT COULD HAVE BEEN BROKEN DURING SHIPMENT, BUT THEY HAVE NO WAY OF KNOWING WHEN THE TUBE WAS BROKEN. THE RESULTS OF THE QUALITY INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAERVELDT GLAUCOMA IMPLANT Implant GLAUCOMA IMPLANT KYF PHARMACIA BV PRODUCTION BG-101-350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA