BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAIN BUSTER WITH 5" ANTIMICROBIAL SILVERSOAKER AND SILVER DRESSING

    MDR report key: 2071410 · Received April 21, 2011

    Report

    Report Number
    MW5020371
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 18, 2011
    Manufacturer
    I-FLOW CORPORATION
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT POST OP C-SECTION WITH ON-Q CATHETER IN INCISION. SURGEON WAS REMOVING ON-Q CATHETER WHEN IT SNAPPED. BLACK TIP WAS NOT VISIBLE AT THE END OF THE CATHETER. PT SENT FOR FLAT PLATE OF THE ABDOMEN. NO DEVICE/CATHETER VISIBLE ON FLAT PLATE AND PRODUCT PACKAGING DOES NOT INDICATE THAT THE DEVICE IS RADIO-OPAQUE. DATES OF USE: (B)(4) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAIN BUSTER WITH 5" ANTIMICROBIAL SILVERSOAKER AND SILVER DRESSING PAIN BUSTER PUMP MEB I-FLOW CORPORATION P<024-A 0C2942

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization