BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1217052-2005-00060

    MDR report key: 743853 · Received July 15, 2005

    Report

    Report Number
    1217052-2005-00060
    Event Type
    Malfunction
    Date Received
    July 15, 2005
    Product Code
    CAI
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    H.6 RESULTS EVAL CODES: SMITHS MEDICAL ASD, INC. HAD REC'D A RECALL PACKAGE FROM OUR MFR OF THIS DEVICE (MMS) IN 02/2005. THIS EVENT REPORT WAS REC'D BEFORE THIS HOSP HAD RETURNED THE REQUESTED UNITS PER THE RECALL INSTRUCTIONS. THE INSTRUCTIONS FOR USE HAVE INSTRUCTIONS FOR PRETESTING THE UNIT BEFORE USE. THIS DEVICE DEFECT SHOULD HAVE BEEN FOUND DURING THE PRETESTING OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAI

    Patients

    Seq Age Sex Outcome Treatment
    1