BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 3853507 · Received May 29, 2014

    Report

    Report Number
    1000125279-2014-00003
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K925636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WAITING ON FURTHER INFORMATION FROM DOCTOR. THE RESULTS OF THE INVESTIGATION ARE PENDING. THE PATIENT IS CURRENTLY BACK TO PRE-OPERATIVE IOP WITH NO SURGERY PLANNED IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    DR. (B)(6) WAS UNABLE TO PRIME VALVE (B)(4) (LOT H0112). THE DOCTOR REPORTED USING SURGICAL TOOL TO RIP THE INTERNAL VALVE SHEET TO ALLOW FLOW. DAMAGING THE INTERNAL VALVE SHEET TO ALLOW FLOW. DAMAGING THE INTERNAL SHEET PREVENTS THE VALVE FROM FUNCTIONING NORMALLY. THE PATIENT EXPERIENCED PERSISTENT LOW IOP UNTIL THE VALVE WAS EXPLANTED ON (B)(6) 2014. THE PATIENT CURRENTLY HAS HIGH IOP WITH NO IMPLANT PLANNED IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315675 AHMED GLAUCOMA VALVE GLAUCOMA SHUNT KYF NEW WORLD MEDICAL, INC. FP7 H0112

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANTI-INFLAMMATORY MEDICATION| IOP LOWERING MEDICATION