BEUDAMED
    FDA Adverse Event Other Summary report: N

    CALAXO - UNKNOWN

    MDR report key: 1082963 · Received July 25, 2008

    Report

    Report Number
    1219602-2008-00174
    Event Type
    Other
    Date Received
    July 25, 2008
    Report Date
    June 23, 2008
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIV.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RECALL INITIATED ON AUGUST 21, 2007. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A REVIEW OF THE COMPLAINT AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE COMPLETED IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNKNOWN POST-OP CONDITION WITH CALAXO SCREW. NO DETAILS HAVE BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALAXO - UNKNOWN CALXO HWC SMITH & NEPHEW INC., ENDOSCOPY DIV. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1