BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAIN PUMP

    MDR report key: 1872270 · Received September 8, 2010

    Report

    Report Number
    2026095-2010-00142
    Event Type
    Other
    Date Received
    September 8, 2010
    Date of Event
    September 26, 2006
    Report Date
    January 20, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS RECEIVED FROM THE FDA, MEDWATCH (B)(4). AS NO CUSTOMER INFO WAS PROVIDED, NO FURTHER INFO COULD BE OBTAINED. WITHOUT THE CONTACT INFO, ACTUAL PRODUCT, LOT, OR SPECIFIC EVENT INFO, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND THE LOT HISTORY CANNOT BE REVIEWED.

    Description of Event or Problem · 1

    USE OF POSTOPERATIVE PAIN PUMP DESTROYED SHOULDER CARTILAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other