BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONOLONG SONO

    MDR report key: 7098937 · Received December 8, 2017

    Report

    Report Number
    9611612-2017-00016
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 12, 2017
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K113188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(4) DISTRIBUTION SUBSIDIARY (B)(4). 2 LOT WERE REPORTED: 1216 = (B)(6) 2017 (MFR.). 1222 = (B)(6) 2017 (MFR.) BASED ON RISK ASSESSMENT AND CLINICAL EVALUATION FILE IS CONSIDERED AS CLOSED.

    Additional Manufacturer Narrative · 1

    EVENT TOOK PLACE IN (B)(6) AND HAS BEEN REPORTED THROUGH (B)(6) - PAJUNK MEDICAL PRODUKTE (B)(4). 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.

    Description of Event or Problem · 1

    IRN# (B)(4). TENTATIVE TRANSLATION AND SUMMARY OF INITIAL REPORTER NARRATIVE: RUPTURE - FRAGMENT REMAINS WITH PATIENT.

    Description of Event or Problem · 1

    (B)(4). TENTATIVE TRANSLATION AND SUMMARY OF INITIAL REPORTER'S NARRATIVE: RUPTURE - FRAGMENT REMAINS WITH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879099 SONOLONG SONO CONTINUOUS PERIPHERAL ANAESTHESIA CONDUCTING KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531187-31A 1216

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention