BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENLO FLO SUCTION IRRIGATOR PROBE

    MDR report key: 20911 · Received August 11, 1994

    Report

    Report Number
    20911
    Event Type
    Malfunction
    Date Received
    August 11, 1994
    Date of Event
    January 24, 1994
    Report Date
    July 21, 1994
    Manufacturer
    DAVOL, INC.
    Product Code
    KAK
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    IRRIGATOR/ASPIRATOR NOTED TO HAVE A PIECE OF RUBBER WASHER MISSING POST SURGERY.INVALID 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENLO FLO SUCTION IRRIGATOR PROBE KAK DAVOL, INC. PROBE WITH LASER CHANNEL

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other