BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DONJOY

    MDR report key: 1034330 · Received April 25, 2008

    Report

    Report Number
    2031921-2008-00006
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    January 1, 2005
    Report Date
    March 25, 2008
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    MEB
    PMA / PMN Number
    K032642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER BECAME AWARE OF THE PATIENT INJURY AS A RESULT OF A LAWSUIT. THE LOCAL ANESTHESIA KIT DESCRIBED BY THE CUSTOMER IS CURRENTLY MANUFACTURED AND MARKETED BY CURLIN MEDICAL. CURLIN MEDICAL ACQUIRED THE DESIGN OF THE PRODUCT IN AUGUST 2006 FROM THE ORIGINAL MANUFACTURER, MCKINLEY MEDICAL, LLC. SINCE THE ACQUISITION OF THE PRODUCT LINE, CURLIN MEDICAL HAS RECEIVED NO COMPLAINTS OF THIS NATURE FOR PRODUCT DISTRIBUTED. CURLIN IS SUBMITTING THIS REPORT AS THE CURRENT MANUFACTURER OF THE DEVICE. THE INITIAL REPORTER IS UNABLE TO PROVIDE THE EXACT DATE OF THE EVENT (IE, WHEN INJURY TO THE PATIENT'S SHOULDER WAS DIAGNOSED). THE INITIAL REPORTER IS UNABLE TO PROVIDE DETAILED INFORMATION REGARDING USE OF THE DEVICE, SUCH AS LOCATION OF CATHETER PLACEMENT AND MEDICATION USED. THE INITIAL REPORTER IS UNABLE TO PROVIDE INFORMATION WITH RESPECT TO DIAGNOSIS AND TREATMENT OF THE PATIENT AS A RESULT OF THE INJURY. THE INITIAL REPORTER IS UNABLE TO PROVIDE INFORMATION REGARDING THE PATIENT'S PREEXISTING MEDICAL CONDITIONS OR SIGNIFICANT MEDICAL HISTORY THAT MAY HAVE CONTRIBUTED TO THE INJURY. CURLIN MEDICAL IS SUBMITTING THIS REPORT WITHIN 30 DAYS AFTER BECOMING AWARE OF THE EVENT. AS OUR INVESTIGATION CONTINUES CURLIN WILL FILE A SUPPLEMENT IF ADDITIONAL INFORMATION BECOMES, AVAILABLE. ADD'L DEVICE: MODEL 11-1352, CATALOG 11-1352, LOT #60567288, EXPIRATION DATE: 04/30/2006.

    Description of Event or Problem · 1

    CURLIN MEDICAL WAS INFORMED OF A REPORTABLE EVENT BY A DISTRIBUTOR, INVOLVING TWO DEVICES. ALL INFORMATION RELATING TO THIS EVENT WAS PROVIDED BY THE DISTRIBUTOR. THE CUSTOMER REPORTED THAT A PATIENT SUFFERED PERMANENT DAMAGE TO THEIR SHOULDER JOINT FOLLOWING SHOULDER SURGERIES. BOTH SHOULDER SURGERIES INVOLVED POST OPERATIVE PAIN MANAGEMENT WITH A LOCAL ANESTHESIA KIT. THE FIRST USE OF THE DEVICE WAS 2004, THE SECOND USE IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONJOY LOCAL ANESTHESIA KIT MEB CURLIN MEDICAL, INC. 11-1352 60526871

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability