BEUDAMED
    FDA Adverse Event Death Summary report: N

    DORNIER

    MDR report key: 6399 · Received August 31, 1993

    Report

    Report Number
    6399
    Event Type
    Death
    Date Received
    August 31, 1993
    Date of Event
    June 29, 1993
    Report Date
    August 4, 1993
    Manufacturer
    DORNIER
    Product Code
    LNS
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT. UNDERWENT EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER ON 6/28/93, 2700 SHOCKS WERE USED. PT. DISMISSED ABOUT 200 PM. PT. RETURNED TO SAME DAY INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: INHERENT RISK OF PROCEDURE. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORNIER EXTRA CORPOREAL SHOCK WAVE LITHOTRIPTER LNS DORNIER HM3

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death