BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DECKER MICRO RONGEUR

    MDR report key: 1161043 · Received June 3, 2008

    Report

    Report Number
    1226348-2008-00145
    Event Type
    Malfunction
    Date Received
    June 3, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HTX
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MFG RECORDS HAVE BEEN REVIEWED AND THEY REVEALED THAT THE DEVICE CONFIRMED TO ALL MFG AND QUALITY TESTING/INSPECTION SPECS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVAL. THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVAL NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DECKER MICRO RONGEUR RONGEUR, MANUAL HTX CODMAN & SHURTLEFF, INC. NA 017

    Patients

    Seq Age Sex Outcome Treatment
    1