BEUDAMED
    FDA Adverse Event Summary report: N

    UNK

    MDR report key: 4544436 · Received February 20, 2015

    Report

    Report Number
    1047429-2015-00001
    Date Received
    February 20, 2015
    Report Date
    February 18, 2015
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL INC. IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY THAT CONTAINS LIDOCAINE MANUFACTURED BY (B)(4). AVID MEDICAL INC. RECEIVED A COMPLAINT ON (B)(6) 2015 FROM (B)(6) THAT ONE EACH OF LIDOCAINE 5ML AMP 1% (B)(4) PART NDC #0409-4713-65 LOT #430453A "DOES NOT SEEM TO BE WORKING". WE HAVE FOLLOWED UP WITH MS. (B)(6) ON FOUR OCCASIONS; HOWEVER, WE HAVE BEEN UNABLE TO OBTAIN ANY FURTHER INFORMATION ON THE EVENT OR THE STATUS OF THE PATIENT. AVID MEDICAL INC. ISSUED A COMPLAINT ON 01/21/2015 TO (B)(4), THE MANUFACTURER OF THE LIDOCAINE, AND ON (B)(6) 2015 SHIPPED 3 AMPULES OF THE COMPLAINED LOT OF LIDOCAINE TO (B)(4) FOR THEIR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124295 UNK MED AVID MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1