BEUDAMED
    FDA Adverse Event Other Summary report: N

    FUSE GEL 1CC

    MDR report key: 3063095 · Received April 12, 2013

    Report

    Report Number
    3000215346-2013-00002
    Event Type
    Other
    Date Received
    April 12, 2013
    Date of Event
    February 26, 2013
    Report Date
    April 12, 2013
    Manufacturer
    ALLOSOURCE
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INITIAL REVIEW OF ALL RELEVANT PROCEDURES, SPECIFICATION, AND PROCESSING RECORDS INDICATED THE DEVICE WAS MANUFACTURED ACCORDINGLY WITH NO DEVIATIONS OR ANOMALIES THAT WOULD HAVE IMPACTED THE QUALITY OF THE DEVICE. THE DEVICE IS TERMINALLY STERILIZED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, ALLOSOURCE WAS NOTIFIED OF A POTENTIAL ADVERSE EVENT IN THE FORM OF A COMPLAINT. AS STATED IN THE COMPLAINT, "THREE WEEKS AFTER SURGERY, PT RETURNED FOR FOLLOW-UP APPOINTMENT WITH ABNORMAL SWELLING NOTED AT SURGICAL SITE. THE SITE WAS OPENED; PUSS AND DBM WERE EXPRESSED." QUESTIONNAIRE DETAILED THE DATE OF IMPLANTATION OF (B)(6) 2013, TO REPAIR RIGHT ULNA SHAFT FRACTURE. PHYSICIAN STATED THE PT IS (B)(6) AND BELIEVES THAT "THE ALLOGRAFT DID NOT CONTRIBUTE TO THIS PT'S INFECTION. SHE HAS MULTIPLE REASONS TO BE AT INCREASED RISK FOR INFECTION." ALLOGRAFT WAS REMOVED AND CULTURED. THE RESULTS WERE NEGATIVE FOR GROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157342 FUSE GEL 1CC NONE MQV ALLOSOURCE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other