BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASEPT PLERUAL DRAINAGE SYSTEM

    MDR report key: 2483318 · Received March 2, 2012

    Report

    Report Number
    2032582-2012-00001
    Event Type
    Other
    Date Received
    March 2, 2012
    Date of Event
    January 23, 2012
    Report Date
    March 2, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    DWM
    PMA / PMN Number
    K093307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, PFM IS UNABLE TO CONFIRM THE NATURE OF THIS COMPLAINT. WITHOUT A LOT NUMBER AND WITHOUT THE NON-CONFORMING SAMPLE, PFM IS UNABLE TO COMPLETE A THOROUGH INVESTIGATION OF THE REPORTED ISSUE. AS THIS WAS THE FIRST INSTANCE OF THIS TYPE OF COMPLAINT, PFM SHALL CONTINUE TO MONITOR FOR FUTURE RECURRENCE. NO CORRECTIVE ACTION IS PLANNED AT THIS TIME. CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN. METHOD: DEVICE DISCARDED, UNABLE TO FOLLOW-UP. RESULTS: INFECTION, SAMPLES-FAILURE TO OBTAIN.

    Description of Event or Problem · 1

    THE CLIENT REPORTED "ASEPT PATIENT CAME TO HOSPITAL WITH DEBRIS (FIBRINOUS TISSUE) IN THE CATHETER. THE CATHETER HAS BEEN IMPLANTED FOR 3 MONTHS. PHYSICIAN INFUSED TPA AND CLEARED THE CATHETER, BUT THE CATHETER BECAME INFECTED AND HAD TO BE REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASEPT PLERUAL DRAINAGE SYSTEM TUNNELED THORACIC CATHETER AND ACCESSORIES DWM PFM MEDICAL, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening