BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOLONG ECHO

    MDR report key: 5895859 · Received August 23, 2016

    Report

    Report Number
    9611612-2016-00111
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    August 12, 2016
    Report Date
    September 9, 2016
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K113188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(4) DISTRIBUTION SUBSIDIARY (B)(4), THE USER AND (B)(6). CURRENTLY THE DATA IS POOR AND THE DEVICE HAS NOT BEEN SENT BACK/ ANALYSED. AS SOON AS FURTHER DATA WILL BE AVAILABLE A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY.

    Additional Manufacturer Narrative · 1

    AS SOON AS FURTHER SIGNIFICANT DATA WILL BE AVAILABLE, A FOLLOW UP REPORT WILL BE SENT IN TO THE AGENCY. BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION, FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). SUMMARIZING TRANSLATION FROM USER'S NARRATIVE: UPON STIMULATING THE COATED NEEDLE USING A BRAUN HNS NERVE STIMULATOR THE NEEDLE FAILED, NO IMPULSE WAS APPLIED. HAPPENED 4 TIMES USING THE SAME STIMULATOR BY 3 DIFFERENT ANAESTHESIA PHYSICIANS; 3 NEEDLES HAVE BEEN DISCARDED, ONLY 1 DEVICE AVAILABLE FOR INVESTIGATION; CAN BE PICKED UP ALONG WITH UNUSED NEEDLES FROM THE SAME LOT FOR ANALYSIS AFTER HOLIDAY.

    Description of Event or Problem · 1

    (B)(4). SUMMARIZING TRANSLATION FROM USER'S NARRATIVE: UPON STIMULATING THE COATED NEEDLE USING A BBRAUN HNS NERVE STIMULATOR, THE NEEDLE FAILED, NO IMPULSE WAS APPLIED. HAPPENED 4 TIMES USING THE SAME STIMULATOR BY 3 DIFFERENT ANAESTHESIA PHYSICIANS; 3 NEEDLES HAVE BEEN DISCARDED, ONLY 1 DEVICE AVAILABLE FOR INVESTIGATION; CAN BE PICKED UP ALONG WITH UNUSED NEEDLES FROM THE SAME LOT FOR ANALYSIS AFTER HOLIDAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550324 SONOLONG ECHO PERIPHERAL NERVE BLOCK NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 531185-31A 1161

    Patients

    Seq Age Sex Outcome Treatment
    1 Other