BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO-SP-1/2X1/2"-STRL 20/CS

    MDR report key: 21798319 · Received April 8, 2025

    Report

    Report Number
    1060680-2025-00021
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 9, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, "THE STRING BECAME DETACHED FROM THE NEURO SPONGE AND THE STAFF DIDN'T KNOW OR COULDN'T FIND THE STRING." THE USER FACILITY ALSO REPORTED THAT THERE WERE NO OUTCOMES OR INJURIES REPORTED WITH THIS MALFUNCTION. DEROYAL INDUSTRIES, INC. REQUESTED THE RETURN OF THE DEVICE HOWEVER IT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CUSTOMER CONFIRMED THEY IDENTIFIED THE PRODUCT INCORRECTLY AND IT WAS NOT FROM DEROYAL INDUSTRIES, INC. AND THEREFORE THIS REPORT IS NOT NEEDED FROM DEROYAL. THERE WILL BE NO INVESTIGATION AS THIS COMPLAINT INCORRECTLY IDENTIFIED PRODUCT AND IS THEREFORE COMPLETE AT THIS TIME.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "THE STRING BECAME DETACHED FROM THE NEURO SPONGE AND THE STAFF DIDN'T KNOW OR COULDN'T FIND THE STRING." THE USER FACILITY ALSO REPORTED THAT THERE WERE NO OUTCOMES OR INJURIES REPORTED WITH THIS MALFUNCTION.

    Description of Event or Problem · 0

    CUSTOMER CONFIRMED THEY IDENTIFIED THE PRODUCT INCORRECTLY AND IT WAS NOT FROM DEROYAL INDUSTRIES, INC. AND THEREFORE THIS REPORT IS NOT NEEDED FROM DEROYAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585250 NEURO-SP-1/2X1/2"-STRL 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-054 24102694

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown