BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-SPECIAL-COMBINED-M4/TT4/H4.3

    MDR report key: 2112395 · Received May 23, 2011

    Report

    Report Number
    2028924-2011-00001
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 23, 2011
    Manufacturer
    IMPLANTECH ASSOCIATES, INC.
    Product Code
    LZK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 125 PRODUCTS.) PRODUCT LABELING ADDRESSES THE POSSIBILITY OF INFECTION.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT PT INDICATED THAT SWELLING OCCURRED SHORTLY AFTER SURGERY. ON (B)(6) 2011, SWELLING WAS ASPIRATED, AND THE FLUID SUBMITTED FOR CULTURE. ULTIMATELY, MYCOBACTERIUM CHELONAE WAS IDENTIFIED. PT HAS BEEN TREATED WITH ORAL CIPRO AND VIOXIN. THE SWELLING RESPONDS TO THIS INTERVENTION AND PT HAS NOT REFLARED YET AFTER LAST TIME. SURGERY TO EXPLANT THE DEVICE IS NOT PLANNED, BUT IT MAY BE NEEDED IF INFECTION DOES NOT RESOLVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-SPECIAL-COMBINED-M4/TT4/H4.3 MALAR IMPLANT LZK IMPLANTECH ASSOCIATES, INC. NA 838042

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention