BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER PAIN PUMP

    MDR report key: 1071570 · Received July 9, 2008

    Report

    Report Number
    MW5007571
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    May 20, 2002
    Report Date
    July 2, 2008
    Manufacturer
    STRYKER INC.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2002, RIGHT SHOULDER SLAP TEAR - SURGERY, AND THE SHOULDER JOINT WAS INSUFFLATED WITH 20CC OF 0.25% MARCAINE WITH EPINEPHRINE. THE STRYKER PAIN CATHETER PLACED ATTACHED TO ITS RESERVOIR OF 120 CC OF 0.25% MARCAINE WITH EPINEPHRINE. TWO DAY INFUSION SET. ON FOUR AND A HALF MONTHS LATER, SURGERY FOR FROZEN RIGHT SHOULDER, ARTHROSCOPY REVEALED THERE WAS GRADE 3 CHONDROMALACIA OF THE GLENOID, BUT HUMERAL HEAD WAS SPARED AND ACTUALLY IN GOOD CONDITION. SHOULDER JOINT WAS INSUFFLATED WITH 30CC OF 0.25% MARCAINE WITH EPINEPHRINE AND THE STRYKER PAIN CATHETER WAS PLACED FOR 48 HOURS. IN 2007, RIGHT SHOULDER X-RAY: SHOW SEVERE BONE ON BONE OSTEOARTHROSIS. ON TWO MONTHS LATER, RIGHT TOTAL SHOULDER ARTHROPLASTY. DOSE OR AMOUNT: #1: 120 CC, #2: UNK. FREQUENCY: 2.08 CC/HR; 48 HOURS DOSAGE. DATES OF USE: 2002. DIAGNOSIS OR REASONS FOR USE: RIGHT SHOULDER SLAP TEAR, FROZEN RIGHT SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PAIN PUMP STRYKER PAIN PUMP 2 DAY INFUSION SET MEB STRYKER INC. UNK UNK
    2 STRYKER PAIN PUMP STRYKER PAIN PUMP 2 DAY INFUSION SET MEB STRYKER INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.25% MARCAINE WITH EPINEPHRINE (STRENGTH UNK)| 0.25% MARCAINE WITH EPINEPHRINE 1:200