BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FLOW

    MDR report key: 1071555 · Received July 9, 2008

    Report

    Report Number
    MW5007557
    Event Type
    Injury
    Date Received
    July 9, 2008
    Date of Event
    December 27, 2006
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2006 SUTURE CAPSULORRHAPHY/ LIGAMENT ARM-SHOULDER ARTHROSCOPY; ANESTH INJECT PERIPH NERVE & LEFT SHOULDER JOINT, ON-Q PAIN BUSTER PAIN PUMP PLACEMENT. IN 2007 LEFT SHOULDER ARTHROSCOPY LYSIS OF ADHESIONS FOR ADHESIVE CAPSULITIS AND CHONDROLYSIS AFTER PREVIOUS ARTHROSCOPIC BANKART STABILIZATION SHOWED SOME GLENOID BONE LOSS ALONG THE ANTERIOR AND INFERIOR THIRD PER SURGEON'S REPORT. DOSE OR AMOUNT: 270 ML. DATE OF USE: 2006. DIAGNOSIS OR REASON FOR USE: CHRONIC LEFT SHOULDER DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-FLOW ON-Q PAIN BUSTER MEB I-FLOW UNK LOT # 652712

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability 0.5% MARCAINE W/ EPINEPHRINE