BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R.E.C. (RACZ EIPDURAL CATHETER)

    MDR report key: 2185453 · Received July 12, 2011

    Report

    Report Number
    1316297-2011-00001
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    April 20, 2011
    Report Date
    July 12, 2011
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    PMA / PMN Number
    954584
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EPIMED FOR EVAL.

    Description of Event or Problem · 1

    AN EPIMED CATHETER WAS SHEARED BY THE INTRODUCER NEEDLE LEAVING APPROX 10 CM INSIDE THE PT. THE PT DID NOT SHOW OUTWARD SIGNS OF DISCOMFORT. IT WAS SUGGESTED TO THE PHYSICIAN THAT A NEUROSURGEON BE CONSULTED REGARDING THE NECESSITY TO INTERVENE TO REMOVE THE REMAINDER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R.E.C. (RACZ EIPDURAL CATHETER) EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. 155-1353 11533349

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other