BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRATORY DENTAL

    MDR report key: 22137 · Received April 17, 1995

    Report

    Report Number
    22137
    Event Type
    Injury
    Date Received
    April 17, 1995
    Date of Event
    April 13, 1995
    Report Date
    April 14, 1995
    Manufacturer
    KENT DENTAL
    Product Code
    EHZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE THE TIP OF THE ORAL ASPIRATOR WAS NOTED TO BE MISSING. COULD NOT BE LOCATED ABOVE CORDS. PT DEVELOPED COUGH AND WHEEZING. REQUIRED BRONCHOSCOPY FOR TIP REMOVAL.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRATORY DENTAL ORAL ASPIRATOR EHZ KENT DENTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention