BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSTAILE 1 WOUND VACUUM SYSTEM

    MDR report key: 1031505 · Received August 14, 2007

    Report

    Report Number
    2032666-2007-00002
    Event Type
    Other
    Date Received
    August 14, 2007
    Date of Event
    November 21, 2005
    Report Date
    August 14, 2007
    Manufacturer
    BLUESKY MEDICAL GROUP INC.
    Product Code
    GCY
    PMA / PMN Number
    K042134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LOT NUMBER WERE NOT AVAILABLE FOR EVAL. NUMEROUS ATTEMPTS WERE MADE TO CONTACT THE REPORTER BY PHONE. NO CALLS WERE RETURNED. WRITTEN CORRESPONDENCE WAS SENT AND NO RESPONSE HAS BEEN RECEIVED TO DATE. THE REGIONAL AUTHORIZED PROVIDER WAS CONTACTED BY PHONE AND NO CALLS WERE RETURNED. WRITTEN CORRESPONDENCE WAS SENT AND NO RESPONSE HAS BEEN RECEIVED TO DATE. TO DATE, NO ADD'L INFO HAS BEEN OBTAINED REGARDING THE EVENT OR THE DEVICE. IN THE EVENT ADD'L INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON 01/02/2007, BLUESKY MEDICAL BECAME AWARE OF A BLUESKY MFG PROD IN THE FDA MAUDE DATABASE, ADVERSE EVENT REPORT. THE FOLLOWING INFO WAS RECEIVED FROM THE INITIAL REPORTER: PT HAD A TRAUMATIC EVENT TO HIS LEFT LEG IN 2005. TREATED BY ORTHO WITH DEBRIDGEMENT. WOUND VAC (KCI) PLACED. REFERRED TO WOUND CLINIC, WITH VAC THERAPY, WOUND IMPROVED. PLANNED FOR SKIN GRAFT. THERAPY CHANGED WITHOUT RPTR'S KNOWLEDGE TWO MOS LATER TO BLUESKY SYS. ARRIVED TO OR. NOT GRAFTABLE. WOUND DETERIORATED / INFECTED. REAPPLIED KCI VAC. GRAFTED 2 MOS LATER. WOUND CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSTAILE 1 WOUND VACUUM SYSTEM POWERED SUCTION PUMP GCY BLUESKY MEDICAL GROUP INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other