BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKWOOD UNDERMINER

    MDR report key: 694083 · Received March 29, 2006

    Report

    Report Number
    2025576-2006-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2006
    Date of Event
    March 6, 2006
    Report Date
    March 23, 2006
    Manufacturer
    BYRON MEDICAL, INC.
    Product Code
    GDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A FACILITY USED A LOCKWOOD UNDERMINER FOR A SURGICAL PROCEDURE WHILE PERFORMING A FULL BODY LIFT. THE PATIENT INDICATES THAT DUE TO THE SUBSEQUENT SURGERY SHE HAS DEVELOPED A SEVERE INFECTION. THE FACILITY INDICATED THAT A GAP BETWEEN THE UNDERMINER AND THE HANDLE COULD BE A POTENTIAL DEFECT. THE FACILITY INDICATED THAT THEY BELIEVE THE ROOT CAUSE OF THE INFECTION STEMS FROM THE PATIENT ALLOWING HER DOGS TO SLEEP AGAINST HER INCISION SITES WHEN SHE WAS AT HOME RECOVERING IMMEDIATELY AFTER THE PROCEDURE. THE FACILITY HAS QUANRANTINED ALL EQUIPMENT USED IN THE PROCEDURE AND BYRON MEDICAL INC. WILL NOT AT THIS TIME RECEIVED THE LOCKWOOD UNDERMINER BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKWOOD UNDERMINER DISSECTOR GDI BYRON MEDICAL, INC. LU383 LST

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other