BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALFOUR RETRACTOR

    MDR report key: 1063779 · Received June 19, 2008

    Report

    Report Number
    1423507-2008-00049
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 19, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVAL AND FORWARDED ON TO THE MANUFACTURING FACILITY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY RECENTLY PURCHASED THIS PRODUCT AND THAT THE SURGEON COMPLAINS WHEN HE USES IT BECAUSE THE MOVABLE ARM OF THE RETRACTOR DOES NOT LOCK FIRMLY IN PLACE. AS HE'S USING IT, THE ALARM SLIDES AROUND INTO DIFFERENT POSITIONS. ADDITIONALLY, ACCOUNT STATED THE PHYSICIAN HAD THE RETRACTOR IN THE PT'S INCISION SITE DURING THE PROCEDURE AND IT CLOSED. THE PHYSICIAN COULD NOT GET THE RETRACTOR TO STAY OPEN SO, HE GOT A LAP SPONGE AND TIED IT OPEN. THE CASE WAS COMPLETED WITHOUT FURTHER DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALFOUR RETRACTOR RETRACTOR GAD CARDINAL HEALTH SU3062 G05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention