BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION DEVICE

    MDR report key: 3901762 · Received May 8, 2014

    Report

    Report Number
    9615741-2014-00023
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    NEWDEAL SAS
    Product Code
    HSB
    PMA / PMN Number
    K091788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THIS IS THE SECOND REPORT OF TWO REPORTS. (SEE MFG REPORT NUMBER 9615714-2014-00022). THIS REPORT CONCERNS THE COMPRESSION DEVICE (B)(4). IT WAS REPORTED THAT DURING SURGERY, THE METALLIC COMPRESSION DEVICE DID NOT ENTER EASILY IN THE PLASTIC SUPPORT AFTER INSERTION OF CALCANEAL SCREWS. THE SURGEON USED 'LIQUID VASELINE' TO LUBRICATE THE DEVICE AND EASILY INSERT THE DEVICE IN THE PLASTIC SUPPORT. SURGERY TIME WAS INCREASED BY 5 MINUTES. THERE WAS NO INJURY OR ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279125 COMPRESSION DEVICE PANTA NAIL HSB NEWDEAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR