BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV.

    MDR report key: 8407854 · Received March 11, 2019

    Report

    Report Number
    3004721439-2019-00070
    Event Type
    Injury
    Date Received
    March 11, 2019
    Date of Event
    February 26, 2019
    Report Date
    November 7, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION NOT PERFORMED. PERMEABILITY TEST NOT PERFORMED. ADJUSTMENT TEST NOT PERFORMED. BRAKING FORCE AND BRAKE FUNCTION TEST NOT PERFORMED. RESULTS THE SHUNT SYSTEM WAS SUBMITTED DRY AND WITH SIGNIFICANT BLOODY RESIDUE. DUE TO THE CONDITION, THE SHUNT SYSTEM WAS RECEIVED IN AND THE NOTED RISK OF INFECTION, WE HAVE DETERMINED THAT THE RISK LEVEL OF THIS SPECIMEN IS TOO GREAT TO ALLOW FOR INSPECTION BY OUR EMPLOYEES. FOR THIS REASON, THE SPECIMEN HAS NOT BEEN INSPECTED AND HAS BEEN RETURNED TO THE SUBMITTING HOSPITAL. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE VALVE MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2Y 5M PO INFECTION. THE EXPLANTED PRODUCT WERE DELIVERED TO MIETHKE IN DRY AND BLOODY STATE. THE FILE IS ENTERED WITH LIMITED INFORMATION. AN INFECTION OF THE PATIENT WAS THE REASON FOR THE REVISION SURGERY. HEIGHT:175CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202538 PROSA SYS W/PROGAV 2.0 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX991T UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention