BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2777464 · Received September 28, 2012

    Report

    Report Number
    1060680-2012-00006
    Event Type
    Other
    Date Received
    September 28, 2012
    Date of Event
    August 29, 2012
    Report Date
    August 29, 2012
    Manufacturer
    CARWILD CORP.
    Product Code
    EFQ
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL REPORTED THAT DURING SURGERY THE NEURO SPONGE DID NOT SHOW ON X-RAY OR FLUOROSCOPY. NEURO SPONGE WAS UNACCOUNTED FOR DURING SURGICAL PROCEDURE. THE PT'S SURGICAL SITE WAS RE-OPENED AND NEURO SPONGE FOUND. DEROYAL: THE SAMPLE HAS NOT BEEN RETURNED TO DEROYAL AT THIS TIME FOR EVALUATION. X-RAY DETECTABLE TESTING WAS PERFORMED ON SAMPLES FROM INVENTORY AND FOUND TO BE ACCEPTABLE. LABELING WAS REVIEWED AND IT WAS DETERMINED TO ADD ADDITIONAL INFORMATION ON X-RAY ELEMENT DETECTION.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING SURGERY THE NEURO SPONGE DID NOT SHOW ON X-RAY OR FLUOROSCOPY. NEURO SPONGE WAS UNACCOUNTED FOR DURING SURGICAL PROCEDURE. THE PT'S SURGICAL SITE WAS RE-OPENED AND NEURO SPONGE FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1