BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER PAINPUMP

    MDR report key: 1063343 · Received June 19, 2008

    Report

    Report Number
    1811755-2008-00026
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 11, 2006
    Report Date
    May 12, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFO HAS BEEN PROVIDED AS TO THE MODEL/CATALOG/LOT NUMBER OF THE STRYKER PAINPUMP THAT WAS USED. NO HOSPITAL OR SURGEON INFO HAS BEEN PROVIDED. NO PRODUCT HAS BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    PER COURT DOCUMENT RECEIVED, THE PT UNDERWENT A LEFT SHOULDER SURGERY AND A STRYKER PAINPUMP WAS PLACED FOLLOWING SURGERY. THE PT NOW ALLEGES LOSS OF CARTILAGE IN HIS SHOULDER, LOSS OF RANGE OF MOTION AND LOSS OF FUNCTIONAL USE OF HIS ARM REQUIRING FUTURE SHOULDER PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PAINPUMP INFUSION PUMP MEB STRYKER INSTRUMENTS KALAMAZOO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention