BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEROYAL

    MDR report key: 2974233 · Received February 12, 2013

    Report

    Report Number
    3004605321-2013-00002
    Event Type
    Other
    Date Received
    February 12, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    S&S SURGICAL
    Product Code
    GDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS DEFECT WAS DETERMINED TO BE AN ISOLATED EVENT. INTERNAL INSPECTIONS WERE PERFORMED DURING THE RELABELING PROCESS AND ON FINISHED GOODS WHERE NO DEFECTS WERE FOUND. AS A CORRECTIVE ACTION ALL APPLICABLE PERSONNEL RECEIVED RETRAINING FOR HEIGHTENED AWARENESS WHEN PACKAGING THIS PRODUCT TO VERIFY THAT THE BLADES ARE NOT EXPOSED. THE PRODUCT IS UNDER 100% INSPECTION TO VERIFY ALL BLADES ARE RETRACTED PRIOR TO PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE STUCK THROUGH THE BOTTOM OF THE BOX CAUSING A MINOR CUT THAT DID NOT REQUIRE MEDICAL ATTENTION. THIS WAS A FIRST AID CASE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62224 DEROYAL GDZ - HANDLE, SCALPEL GDZ S&S SURGICAL 29888883

    Patients

    Seq Age Sex Outcome Treatment
    1 Other