BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAERVELDT SHUNT

    MDR report key: 2818051 · Received November 2, 2012

    Report

    Report Number
    9614546-2012-00187
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    October 18, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    PMA / PMN Number
    K955455
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION SHOWED THAT THE RETURNED SAMPLE HAD BEEN USED. THE TUBE WAS IN AN INCORRECT POSITION AND HAD BEEN CUT. THE CONDITION OF THE RECEIVED SAMPLE INDICATED THAT CUSTOMER HANDLING TOOK PLACE. THE DAMAGE INDICATES THAT AN EXCESSIVE FORCE AND OR HANDLING TOOK PLACE. 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 SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SHUNT WAS IMPLANTED AND THEN EXPLANTED DUE TO THE DOCTOR CUTTING THE TUBING TOO SHORT. THE INCISION WAS ENLARGED FOR THE REMOVAL OF THE SHUNT. THE REPORTER INDICATED THERE WAS NOTHING WRONG WITH THE DEVICE, EVENT WAS DUE TO USER ERROR.

    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 Required Intervention