BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUER-EVAC SAHARA DRAINAGE SYSTEM

    MDR report key: 1702072 · Received May 27, 2010

    Report

    Report Number
    3004365956-2010-00062
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    March 11, 2010
    Report Date
    April 30, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE EVENT AS: AFTER URGENT DRAINAGE OF BILATERAL PNEUMOTHORAXES, THE PT HAD X-RAY EXPLORATION OF THE CHEST. IT WAS FOUND THAT THE DRAINS WERE IN THE PROPER POSITION, BUT THE TENSION PNEUMOTHORAXES PERSISTED. THE DEVICES WERE REPLACED TO A SECOND ONE, BUT CLINICAL SIGNS OF TENSION PNEUMOTHORAXES CONTINUED. AFTER THE DEVICES WERE CHANGED TO A COMPETITIVE SYSTEM, THE PNEUMOTHORAXES DISAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUER-EVAC SAHARA DRAINAGE SYSTEM PLUER-EVAC CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention