BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGARLATO LABS

    MDR report key: 835364 · Received March 30, 2007

    Report

    Report Number
    MW1042457
    Event Type
    Malfunction
    Date Received
    March 30, 2007
    Manufacturer
    SGARLATO LABS
    Product Code
    JDW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTERNAL PACKAGING INDICATES EXPIRATION DATE OF 08/2005. PLACED OVER THIS LABEL IS ANOTHER LABEL INDICATING EXPIRATION DATE OF 08/2008. INTERNAL PACKAGING EXPIRATION DATE INDICATES 08/2005. COMPANY CONTACTED - STATED THEY WERE EXTENDING SHELF LIFE. NO REPROCESSING DONE. LETTER FROM SGARLATO LABS. NOTE: DATE ON LETTER DOES NOT COINCIDE WITH PACKAGING AND FURTHER EXTENDS EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGARLATO LABS SHAW RODS (HAMMERTOE CORRECTION) JDW SGARLATO LABS 90-100-03 091801 D
    2 SGARLATO LABS SHAW RODS (HAMMERTOE CORRECTION) JDW SGARLATO LABS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *