BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AHMED GLAUCOMA VALVE

    MDR report key: 15810057 · Received November 16, 2022

    Report

    Report Number
    1000125279-2022-00047
    Event Type
    Injury
    Date Received
    November 16, 2022
    Date of Event
    October 21, 2022
    Report Date
    February 15, 2023
    Manufacturer
    NEW WORLD MEDICAL, INC.
    Product Code
    KYF
    PMA / PMN Number
    K162060
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE OBSERVED, PRODUCT WAS MANUFACTURED, TESTED AND RELEASED PER VALIDATED PROCEDURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. UNIT HAS NOT BEEN RETURNED FOR EVALUATION. AN ADDENDUM WILL BE FILED WITH UPDATED INFORMATION IF THE UNIT IS RETURNED TO NWM FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    NWM REQUESTED ADDITIONAL INFORMATION REGARDING THE EXPLANT AND ALSO REQUESTED THE RETURN OF THE DEVICE. ON FEBRUARY 2, 2023, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED:  DATE OF IMPLANTATION:(B)(6) 2011, DATE OF EXPLANT: (B)(6) 2022. REASON FOR EXPLANT: "IOP TOO HIGH OU ON MTMT INCLUDING ORAL DIAMOX 1500 MG / DAY. BOTHERED BY THE SIDE EFFECTS OF THE DIAMOX" PRE-OP IOP: 35, POST-OP IOP: 12.  IF EXPLANT, IS THE VALVE AVAILABLE FOR EVALUATION AT NEW WORLD MEDICAL? NO. BAERVELDT WAS IMPLANTED . AGE: 19 WHEN REMOVED, BIRTH DATE: (B)(6) 2002, GENDER: MALE, WEIGHT: 174. HOSPITAL CONFIRMED THAT DEVICE IS NOT AVAILABLE FOR RETURN TO NEW WORLD MEDICAL. AS DEVICE COULD NOT BE RETURNED, THE ISSUE OF HIGH IOP CONDITION AS REPORTED BY CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED, "I HAVE A 19 Y/O PATIENT WHO HAD SEVERAL TUBE SHUNT SURGERIES IN THE PAST AND I HAVE TO TAKE ONE OF THEM OUT. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783426 AHMED GLAUCOMA VALVE GLAUCOMA DRAINAGE DEVICE KYF NEW WORLD MEDICAL, INC. FP7 M0310

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention