BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALAXPRESS, CLEAR, 1000G POWDER

    MDR report key: 2442538 · Received February 1, 2012

    Report

    Report Number
    9610902-2012-00002
    Event Type
    Injury
    Date Received
    February 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION
    Product Code
    EBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT DISTRIBUTED OR SOLD IN THE US. HOWEVER, A SIMILAR PRODUCT IS DISTRIBUTED AND SOLD IN THE US. PRODUCT NAME PALAXPRESS ULTRA, 510K # K110037, WHICH IS BEING INTRODUCED TO THE US MARKET THIS YEAR. PT HAS A KNOWN ALLERGY TO PLASTIC. DENTIST DISREGARDED ALLERGY OR FAILED TO CHECK FOR ALLERGY PRIOR TO DISPENSING DEVICE TO PT. PRODUCT DIRECTIONS FOR USE STATE THAT IF THE PT IS ALLERGIC TO ONE OR MORE INGREDIENTS OF PALAXPRESS, THE PRODUCT MUST NOT BE USED.

    Description of Event or Problem · 1

    THIS IS A REQUEST FROM THE (B)(4) MEDICAL PRODUCT AGENCY (B)(4) FOR A (B)(6) REPORT ON A MEDICAL DEVICE (B)(4). INCIDENT DATE WAS NOT REPORTED. AFTER USE OF PALAXPRESS THE PT EXPERIENCED A STINGING/BURNING FEELING. THE PT ALSO SUFFERS FROM STIFFNESS AND NUMBNESS. THE PT HAS BEEN INFORMED NOT TO USE THE SPLINT AND HE HAS BEEN REFERRED TO A DOCTOR FOR FURTHER INVESTIGATION. THE PT IS REPORTED TO HAVE THE FOLLOWING KNOWN ALLERGIES: ALUMINUM, PLASTIC, FUR ANIMALS, AND SPICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALAXPRESS, CLEAR, 1000G POWDER EBI RESIN, DENTURE, RELINING, REPAIRING, REB EBI HERAEUS KULZER GMBH & CO. KG, MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other