BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 1408014 · Received June 24, 2009

    Report

    Report Number
    1722139-2009-00024
    Event Type
    Injury
    Date Received
    June 24, 2009
    Date of Event
    May 11, 2006
    Report Date
    June 24, 2009
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF CURLIN'S COMPLAINT DATABASE REVEALED NO CORRESPONDING COMPLAINT FOR THIS LAWSUIT. CURLIN MEDICAL CANNOT CONFIRM THE BASIS OF THIS COMPLAINT. SIGNIFICANT TIME HAS PASSED BETWEEN THE EVENT AND THE ALLEGATION OF A PRODUCT DEFECT. NO PRODUCT IS AVAILABLE FOR INVESTIGATION. CURLIN MEDICAL BELIEVES THAT ITS PRODUCTS DO NOT LEAD TO NARROWING OF THE JOINT SPACE AND/OR CHONDROLYSIS WHEN USED ACCORDING TO THE PRODUCT'S LABELING AND DIRECTIONS FOR USE.

    Description of Event or Problem · 1

    ON 06/03/2008, CURLIN MEDICAL, INC. WAS SERVED WITH A LAWSUIT BY PATIENT ALLEGING THAT IN 2006, A BREG BRAND "PAIN PUMP" USING A TUBING/CATHETER SET INSERTED INTO THE PATIENT'S SHOULDER JOINT, POST-ARTHROSCOPIC SURGERY, AND WITH CONTINUOUS INFUSION OF AN UNIDENTIFIED LOCAL ANESTHETIC RESULTED IN NARROWING OF THE JOINT SPACE AND/OR CHONDROLYSIS. SPECIFICALLY, THE PATIENT ALLEGED THAT THE PRODUCT LABELING FOR THE PAIN PUMP WAS INADEQUATE IN THAT IT DID NOT ADEQUATELY WARN ABOUT THE SAFETY OF THE DEVICE; THAT CONTINUOUS JOINT SPACE MAY CAUSE SERIOUS AND PERMANENT INJURY TO THE JOINT CARTILAGE; THAT THE LABELING DID NOT SPECIFICALLY IDENTIFY ANESTHETIC MEDICATIONS THAT COULD BE SAFELY AND EFFECTIVELY USED IN THE SHOULDER JOINT SPACE; AND THAT THE PAIN PUMP DELIVERED, OVER TIME, DANGEROUSLY HIGH DOSES OF MEDICATION DIRECTLY INTO SHOULDER TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MEB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention