BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL

    MDR report key: 3982762 · Received June 17, 2014

    Report

    Report Number
    1060680-2014-00027
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    CARWILD CORP
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEROYAL: THE REPORTED SAMPLE IS NOT AVAILABLE FOR EVAL. DEROYAL'S SUPPLIER HAS BEEN NOTIFIED OF THE ISSUE FOR FURTHER INVESTIGATION TO BE PERFORMED. THE INVESTIGATION INTO THE ROOT CAUSE IS IN PROCESS.

    Description of Event or Problem · 1

    THE END USER REPORTED THAT THEY HAVE CONCERNS WITH THE QUALITY OF THE PATTIES IN THE LAMINECTOMY PACK. THE PATTIES SEPARATE FROM THE STRING AS WE COUNT THEM, WHICH COULD BE A MAJOR PROBLEM WHEN PERFORMING SURGERY ON THE BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355978 DEROYAL GAUZE/SPONGE, INTERNAL EFQ CARWILD CORP

    Patients

    Seq Age Sex Outcome Treatment
    1