BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL PURPOSE PROBE COVER

    MDR report key: 6513010 · Received April 21, 2017

    Report

    Report Number
    8043817-2017-00008
    Event Type
    Malfunction
    Date Received
    April 21, 2017
    Date of Event
    March 10, 2017
    Report Date
    March 23, 2017
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    KKX
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR LOT D160951 AND IT WAS NOTICED THAT THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 04/04/16. NO DEFECTS RELATED TO THE NON CONFORMANCE WERE REPORTED DURING QUALITY INSPECTIONS. THE LEAK TEST REPORT WAS REVIEWED AND ALL RESULTS WERE SATISFACTORY. THIS LOT WAS MANUFACTURED IN 1ST SHIFT. THE MANUFACTURING PROCESS WAS REVIEWED AND IT WAS OBSERVED THAT THE OPERATORS WERE PERFORMING THE MANUFACTURING PROCESS ACCORDING TO SPECIFICATION. NO FURTHER ACTIONS ARE BEING TAKEN AT THIS TIME SINCE NO SAMPLES OR PICTURES WERE RECEIVED FOR THIS INVESTIGATION AND DURING THE PROCESS EVALUATION NO CONDITION THAT REQUIRES MITIGATION WAS OBSERVED.

    Description of Event or Problem · 1

    END USER REPORTED LEAKING ISSUES WITH PC1291 5IN X 24IN PROBE COVERS. NO PATIENT INJURY OR TREATMENT WAS REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291961 GENERAL PURPOSE PROBE COVER PROBE COVER KKX MICROTEK DOMINICANA, S.A. PC1291 D160951

    Patients

    Seq Age Sex Outcome Treatment
    1