BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT

    MDR report key: 6290365 · Received January 31, 2017

    Report

    Report Number
    1226348-2017-10079
    Event Type
    Malfunction
    Date Received
    January 31, 2017
    Date of Event
    December 22, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED UDI: (B)(4). COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. ADDITIONALLY, THE LOT NUMBER PROVIDED DID NOT MATCH ANY LOTS MANUFACTURED FOR THIS DEVICE; THEREFORE, A REVIEW OF MANUFACTURING RECORDS COULD NOT BE PERFORMED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF THE COMPLAINT SAMPLE BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). 510(K) # OF SIMILAR PRODUCT CODE OF 826638: K974088. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (B)(4). THE SENSOR DIDN'T DETECT THE PRESSURE LEVEL. NO PATIENT AES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72886 ROHS MICROSENSOR W/SINGLE LUMEN METAL BOLT KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. CVFF40

    Patients

    Seq Age Sex Outcome Treatment
    1