BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FILLER, BONE VOID, CALCIUM COMPOUND

    MDR report key: 5098859 · Received September 23, 2015

    Report

    Report Number
    1416980-2015-36992
    Event Type
    Injury
    Date Received
    September 23, 2015
    Report Date
    November 20, 2015
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE RECEIPT OF ADDITIONAL INFORMATION, IT WAS REPORTED THAT THIS PATIENT EVENT OF ¿A POTENTIAL INFECTION OR AN INFLAMMATORY REACTION¿ COINCIDENT WITH THE USE OF ACTIFUSE ABX DID NOT OCCUR. THEREFORE, ACTIFUSE IS NO LONGER CONSIDERED A SUSPECT PRODUCT WITH REGARDS TO THIS ERRONEOUS REPORT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL INFECTION OR AN INFLAMMATORY REACTION COINCIDENT WITH THE USE OF ACTIFUSE ABX. THE CAUSE OF THE POTENTIAL INFECTION (NOT FURTHER SPECIFIED) OR THE INFLAMMATORY REACTION (NOT FURTHER SPECIFIED) WAS NOT REPORTED. THE INDICATION FOR USE OF THE ACTIFUSE WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED AND NO FURTHER DETAIL REGARDING THE PATIENT'S OUTCOME WAS PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627973 FILLER, BONE VOID, CALCIUM COMPOUND MQV BAXTER APATECH LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other