BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q 400X2D PM028A

    MDR report key: 2428585 · Received January 20, 2012

    Report

    Report Number
    2026095-2011-00460
    Event Type
    Injury
    Date Received
    January 20, 2012
    Report Date
    December 22, 2011
    Manufacturer
    I-FLOW CORP, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO THE AVAILABLE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. PRODUCT PENDING RECEIPT. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.5%, FILL VOLUME: 400 ML, FLOW RATE: 4ML/HR, PROCEDURE: BREAST AUGMENTATION, CATHPLACE: 10 CM SUPERIOR TO THE INFRA MAMMARY INCISION. CATHETER BROKE OFF WHILE TRYING TO REMOVE (POS 5 DAYS); BLACK DISTAL TIP WAS NOT LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q 400X2D PM028A ELASTOMERIC PUMP MEB I-FLOW CORP, LLC 101372100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1