BEUDAMED
    FDA Adverse Event Summary report: N

    STRATO MEDICAL CORP

    MDR report key: 5239 · Received April 28, 1993

    Report

    Report Number
    5239
    Date Received
    April 28, 1993
    Date of Event
    March 22, 1993
    Manufacturer
    LIFE PORT - STRATOMEDICAL CORP
    Product Code
    BYX
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DISTAL TIP OF LIFEPORT (SILASTIC TUBING) BROKE OFF FROM INJECTION PORT HAD TOBE RETREIVED FROM PATIENT VIA A SPECIAL PROCEDURE IN RADIOLOGY. THE DEVICE WAS NOT IN USE AT THE TIME OF MALFUNCTION. THE EXACT TIME AND LOCATION OF OCCURANCE IS UNKNOWNDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATO MEDICAL CORP Implant LIFEPORT BYX LIFE PORT - STRATOMEDICAL CORP 101706

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Invalid Data