BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2810262 · Received October 31, 2012

    Report

    Report Number
    2020664-2012-00082
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION SHOWED THAT THE RETURNED SAMPLE WAS HEAVILY DAMAGED. THE TUBE AND SETTON WERE BOTH BROKEN. THESE DAMAGES INDICATE THAT EXCESSIVE FORCE AND OR HANDLING TOOK PLACE. NO EVIDENCE OF DAMAGES CAUSED BY TOOLING USED AT THE MANUFACTURING PLANT COULD BE IDENTIFIED. CONCLUSION: THE DEVICE PASSED ALL ACCEPTANCE CRITERIA FOR ALL TESTS PERFORMED AND IS WITHIN ALL SPECIFICATIONS DURING THE MANUFACTURING PROCESS, THEREFORE NO PRODUCTION RELATED CAUSE IS EXPECTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS INC HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SHUNT EXPLANTED BECAUSE THE SHUNT WAS SHIFTING ANTERIORLY, DID NOT SIT FLAT, CAUSING IRRITATION TO THE PATIENT. THERE WAS A TUBE RETRACTION. A DIFFERENT MODEL SHUNT WAS IMPLANTED AT THE TIME OF THE EXPLANT. THE DOCTOR DID NOT FEEL THAT THE ANTERIOR DISPLACEMENT OF THE SHUNT COULD HAVE LED TO A SERIOUS INJURY. THE EXPLANT WAS PERFORMED PRIMARILY DUE TO PATIENT ANATOMY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG101-350

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention