BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23876853 · Received December 23, 2025

    Report

    Report Number
    1060680-2025-00055
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 18, 2025
    Report Date
    December 23, 2025
    Manufacturer
    MEDSORB DOMINICANA, S.A.
    Product Code
    EFQ
    UDI-DI
    50749756037407
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED, " WHEN USING THE NEURO SPONGES REF 30-055 LOT 24112874 EXP 12/11/2029 THE PRODUCT, WHICH IS SUPPOSED TO BE X-RAY DETECTABLE WAS NOT DETECTED ON THE XRAY." DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, BUT HAS NOT YET BEEN RECEIVED. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WILL BE ISSUED TO THE SUPPLIER/MANUFACTURER, MEDSORB DOMINICANA. 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.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "WHEN USING THE NEURO SPONGES REF 30-055 LOT 24112874 EXP 12/11/2029 THE PRODUCT, WHICH IS SUPPOSED TO BE X-RAY DETECTABLE WAS NOT DETECTED ON THE XRAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2507380 NEURO SPNG-1/2X1"-STRL- 20/CS GAUZE/SPONGE, INTERNAL EFQ MEDSORB DOMINICANA, S.A. 30-055 24112874 50749756037407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown