BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOPUMP RAPID RECOVERY SYSTEM

    MDR report key: 2023302 · Received February 15, 2011

    Report

    Report Number
    3005203102-2011-00001
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    May 22, 2007
    Report Date
    March 15, 2011
    Manufacturer
    SYMBIOS MEDICAL PRODUCTS
    Product Code
    MEB
    PMA / PMN Number
    K993972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS MADE TO THE MANUFACTURER MORE THAN 3 YEARS AFTER THE DATE OF USE, WITH INSUFFICIENT INFORMATION UPON WHICH TO IDENTIFY THE PRODUCT LOT NUMBER OR EXPIRATION DATE. PRODUCT PART NUMBER IS SURMISED, BASED UPON THE DESCRIPTION PROVIDED IN THE COMPLAINT. IN VIEW OF THE PUBLISHED RISK OF SHOULDER CHONDROLYSIS, AND IN ADVANCE OF THE (B)(4) 2009 FDA CHONDROLYSIS SAFETY ALERT, LABELING FOR THIS PRODUCT WAS UPDATED (B)(4) 2008, TO INCLUDE A WARNING NOT TO PLACE THE CATHETER TIP IN JOINT SPACES.

    Description of Event or Problem · 1

    COMPLAINT REC'D AS A LEGAL COMPLAINT AGAINST SYMBIOS MEDICAL PRODUCTS. THE DETAILS LISTED HERE ARE EXTRACTED FROM THAT COMPLAINT. "PLAINTIFF UNDERWENT A LEFT SHOULDER ARTHROSCOPIC SURGERY IN (B)(6) ON (B)(6), 2007. BASED ON INFORMATION AND BELIEF, A "SYMBIOS" PAIN PUMP WAS FILLED WITH 100 ML OF .5% MARCAINE (BUPIVACAINE). THE PAIN PUMP'S CATHETER WAS IMPLANTED DIRECTLY INTO PLAINTIFF'S LEFT SHOULDER JOINT SPACE AT THE CONCLUSION OF HER (B)(6), 2007 SURGERY. AS A RESULT, PLAINTIFF SUFFERED NARROWING OF THE JOINT SPACE OF HER LEFT SHOULDER AND/OR A CONDITION CALLED "CHONDROLYSIS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOPUMP RAPID RECOVERY SYSTEM MEB SYMBIOS MEDICAL PRODUCTS 510031 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Disability