BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALCIUM SULFATE HEMIHYDRATE

    MDR report key: 1779020 · Received July 28, 2010

    Report

    Report Number
    1287163-2010-00014
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    April 30, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ACE SURGICAL
    Product Code
    LYC
    PMA / PMN Number
    K051381
    Removal / Correction Number
    Z-1805-2010, Z-1806-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN HAD QUESTIONS REGARDING THE LABELING OF THE 505-2001 KITS. UPON REVIEW OF THE QUESTIONS RAISED BY THE CLINICIAN, IT WAS NOTED THAT THE KIT WAS PROPERLY LABELED AND ALL LOT INFO WAS CORRECT. DURING THE INVESTIGATION, IT WAS NOTICED BY THE NEW DIRECTOR OF COMPLIANCE THAT THE FAST SET SOLUTION IN THE KIT WAS NOT PROVIDED STERILE AS REQUIRED. UPON FURTHER INVESTIGATION, A RECALL WAS INITIATED.

    Description of Event or Problem · 1

    THE CLINICIAN'S OFFICE REPORTED THAT THERE WAS NO EXPIRY DATE PROVIDED ON THE OUTSIDE OF THE PRODUCT KIT AND THE LOT NUMBERS ASSIGNED TO THE COMPONENTS IN THE KIT DO NOT MATCH THE LOT NUMBER ON THE KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALCIUM SULFATE HEMIHYDRATE CALCIUM SULFATE HEMIHYDRATE LYC ACE SURGICAL 505-2001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA