BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2725084 · Received September 4, 2012

    Report

    Report Number
    2020664-2012-00060
    Event Type
    Injury
    Date Received
    September 4, 2012
    Date of Event
    March 16, 2012
    Report Date
    August 7, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE CODE: (B)(4) - BAERVELDT SHUNT. PMA K955455. (B)(4). TO DATE, THE DEVICE REMAINS IMPLANTED. PRIOR TO RELEASE, THE SHUNT MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS (AMO) HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT IMPLANT OF A SHUNT. AT THE DAY ONE (1) POST OPERATIVE VISIT, THE PATIENT WAS DIAGNOSED WITH HYPOTONY. THE SHUNT REMAINS IMPLANTED. NO FURTHER INFORMATION IS AVAILABLE AS THE PATIENT CHANGED HOSPITALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG102-350

    Patients

    Seq Age Sex Outcome Treatment
    1 Other