BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAHARA ADULT UNIT

    MDR report key: 211767 · Received February 25, 1999

    Report

    Report Number
    1221601-1999-00001
    Event Type
    Injury
    Date Received
    February 25, 1999
    Date of Event
    January 31, 1999
    Report Date
    February 1, 1999
    Manufacturer
    GENZYME SURGICAL PRODUCTS CORP.
    Product Code
    KDQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    JOINT BETWEEN TUBING PORT AND SAHARA CANISTER WAS FOUND BROKEN. THE TUBING WAS LYING ON THE FLOOR. STANDARD AM CHEST X-RAY DONE MINUTES PRIOR TO INCIDENT. PT HAD PNEUMOTHORAX THAT WAS RESOLVED BY CHANGING SAHARA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAHARA ADULT UNIT CHEST DRAINAGE DEVICE KDQ GENZYME SURGICAL PRODUCTS CORP. S-1100 304573

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention