BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERSON DISPOSABLE DRAINAGE UNIT

    MDR report key: 4507 · Received June 30, 1992

    Report

    Report Number
    4507
    Event Type
    Malfunction
    Date Received
    June 30, 1992
    Report Date
    June 30, 1992
    Manufacturer
    J.H. EMERSON COMPANY
    Product Code
    EYZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AN EMERSON DISPOSABLE DRAINAGE UNIT BROKE AT THE CONNECTOR SITE TO THE DRAINAGE COLLECTION SYSTEMINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMERSON DISPOSABLE DRAINAGE UNIT EYZ J.H. EMERSON COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other