BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2429537 · Received January 26, 2012

    Report

    Report Number
    2090040-2012-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    December 27, 2011
    Report Date
    December 28, 2011
    Product Code
    GBA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER SUSTAINABILITY SOLUTIONS (SSS) RESTERILIZED THE COMPLAINT DEVICE THROUGH OUR OPEN-BUT-UNUSED PROCESS. THE COMPLAINT DEVICE WAS RETURNED TO SSS IN ITS ORIGINAL SEALED TYVEK POUCH ALONG WITH A SIMILAR DEVICE THAT IS DOCUMENTED IN MDR 2090040-2012-00002. AN INVESTIGATION BASED OFF OF THREE TYPES OF ONLINE CROSS REFERENCE GUIDES FROM THE ORIGINAL MANUFACTURER (OM) INDICATES THE PART NUMBER ON THE LABEL WAS CORRECT HOWEVER THE SIZE DESCRIPTION ON THE LABEL WAS INCORRECT. THE DEVICE ITSELF WAS BRANDED WITH THE SIZE DESCRIPTION ON THE PROXIMAL END. IT CAN BE CONFIRMED THAT THE COMPLAINT DEVICE WAS IDENTIFIED CORRECTLY HOWEVER THE SIZE DESCRIPTION WAS ENTERED INCORRECTLY INTO THE ITEM INFORMATION DATABASE. THE LABEL INDICATED THE SIZE OF THE DEVICE AS 5MM X 6CM HOWEVER IT IS ACTUALLY 6MM X 6CM. THE SIZE IS CORRECT ON THE DEVICE ITSELF. THE SIZE DESCRIPTION IN THE ITEM INFORMATION DATABASE HAS BEEN UPDATED. THIS IS THE FIRST COMPLAINT SSS HAS RECEIVED FOR THE SIZE ON THE LABEL OF THIS DEVICE TYPE BEING INCORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SIZE WAS LISTED INCORRECTLY ON THE DEVICE LABEL. THE DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A GBA GBA 17-633

    Patients

    Seq Age Sex Outcome Treatment
    1