BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENEX PUTTY

    MDR report key: 3350062 · Received September 10, 2013

    Report

    Report Number
    9617083-2013-00015
    Event Type
    Other
    Date Received
    September 10, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 7, 2013
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    PMA / PMN Number
    K062911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED ROOT CAUSES: BASED ON THE INFO PROVIDED, THE DESCRIPTION OF EVENTS AND ABSENCE OF INFECTION SOUNDS CONSISTENT WITH MIGRATION OF GENEX PUTTY. THIS IS A POTENTIAL RISK WHEN USED IN UNCONTAINED DEFECTS. GENEX PUTTY IS INDICATED TO BE GENTLY PACKED INTO VOIDS OR DEFECTS OF THE SKELETAL SYSTEM AND IS SELDOM USED IN LATERAL GUTTERS AS THE AREA CAN BE QUITE BLOODY AND THE PUTTY NOT WELL CONTAINED. THE SURGEON HAD NOT USED THE PRODUCT BEFORE AND MAY HAVE BEEN UNFAMILIAR WITH THE RECOMMENDED USE. THE PT HAS BEEN DISCHARGED AND RETURNED HOME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING: FOLLOWING SURGERY, DURING WASH OUT ON (B)(6) 2013, IT WAS NOTED THAT THERE WAS A REDNESS AROUND THE WOUND AND THAT THERE WAS 'WHITE PUS' EMITTED. THE GENEX PUTTY WAS SEEN TO MIGRATE FROM WHERE IT WAS PUT. INFECTION SUSPECTED, ALTHOUGH LATER CONFIRMED AS BEING NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454217 GENEX PUTTY GENEX PUTTY MQV BIOCOMPOSITES LTD. 03/13-GP98

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention