BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENEX

    MDR report key: 2980018 · Received February 20, 2013

    Report

    Report Number
    9617083-2013-00006
    Event Type
    Other
    Date Received
    February 20, 2013
    Report Date
    September 25, 2012
    Manufacturer
    BIOCOMPOSITES LTD.
    Product Code
    MQV
    PMA / PMN Number
    K091526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVAL IS A POSSIBLE ADVERSE REACTION TO GENEX; HOWEVER, THERE IS A LOW LIKELIHOOD OF PT ADVERSE REACTION TO PRODUCT DUE TO MFG PROCESS CONTROLS. BASED ON THE LIMITED AMOUNT OF INFO RECEIVED, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    FOLLOWING A REVIEW OF THE CUSTOMER COMPLAINT DETAILS, IT WAS CONCLUDED THAT THE DETAILS OF THIS REPORT MET THE MDR REPORTING CRITERIA. THE CUSTOMER REPORTED THAT POSTOPERATIVELY, THE SURGEON NOTICED AN ABNORMAL BONE FORMATION AROUND THE KNEE JOINT OF A FEMALE PT FOLLOWING GENEX APPLICATION TO FILL A BONE VOID AFTER EXCISION OF MALIGNANT NEOPLASM. UPON REOPERATION, HE NOTICED JELLY-LIKE MATERIAL AT THE TUMOR BED WHERE GENEX WAS INITIALLY USED. THE SAME MATERIAL WAS ALSO FOUND IN THE ADJACENT SOFT TISSUES AND MUSCLES AROUND THE SURGICAL SITE. HE DEEMED THAT MATERIAL TO BE THE SOURCE OF THE PT'S POSTOPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75084 GENEX GENEX MQV BIOCOMPOSITES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention