BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TERINO MALAR SHELL-LARGE, 4MM

    MDR report key: 2589899 · Received May 22, 2012

    Report

    Report Number
    2028924-2012-00003
    Event Type
    Injury
    Date Received
    May 22, 2012
    Date of Event
    March 28, 2012
    Report Date
    May 22, 2012
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEWED DEVICE HISTORY RECORDS, STERILIZATION RECORDS, AND PRODUCT LABELING. RESULTS: DEVICE HISTORY RECORDS REVIEW REVEALED NO ASSIGNABLE CAUSE FOR THE REPORTED EVENT. THE STERILIZATION PROCESS WAS WITHIN SPECIFIED PARAMETERS, AND THERE HAVE BEEN NO OTHER REPORTS OF INFECTION INVOLVING THIS STERILE LOT. (TOTAL OF 871 PRODUCTS).

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT SHORTLY AFTER IMPLANTATION WITH MALAR IMPLANTS, THE PT PRESENTED WITH PERSISTENT EDEMA. TWENTY-SIX DAYS POST-OP, THE DEVICES WERE EXPLANTED AND A CULTURE WAS TAKEN. CULTURE RESULTED IN MYCOBACTERIUM CHELONAE/MYCOBACTERIUM ABSCESSUS GROUP. PT WAS SEEING A SPECIALIST FOR THIS TYPE OF INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERINO MALAR SHELL-LARGE, 4MM MALAR IMPLANT LZK NA 820759

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention