BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELLENTRA

    MDR report key: 3651722 · Received February 27, 2014

    Report

    Report Number
    0002242816-2014-00018
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 28, 2014
    Manufacturer
    EBI, LLC.
    Product Code
    MQV
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. IMPLANT DATE - PRODUCT NOT USED. EXPLANT DATE - PRODUCT NOT USED. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME EVENT (ALSO SEE 0002242816-2014-00017 / 00018)

    Description of Event or Problem · 1

    OUTSIDE PACKAGING LABEL DOES NOT MATCH INSIDE PRODUCT LABEL. PRODUCT WAS NOT USED. PATIENT OUTCOME: NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121535 CELLENTRA CELLENTRA VCBM - 1CC MQV EBI, LLC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female