BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURASINUS

    MDR report key: 15102080 · Received July 26, 2022

    Report

    Report Number
    3015528146-2022-00001
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    November 1, 2021
    Report Date
    July 11, 2022
    Manufacturer
    3-D MATRIX, INC
    Product Code
    NHB
    UDI-DI
    00860001820836
    PMA / PMN Number
    K183015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIALLY, 3-D MATRIX (3DM) BECOME AWARE OF THIS EVENT ON OR BEFORE 18NOV2021. THE PREVIOUS QUALITY ASSURANCE MANAGER ATTEMPTED TO CONTACT THE COMPLAINANT ON 18NOV2021. NO FURTHER EVIDENCE OF CONTACT BETWEEN 3DM AND COMPLAINANT. ON 20APR2022, THE NEW QUALITY AND REGULATORY MANAGER BECAME AWARE OF THIS COMPLAINT AND IMMEDIATELY ATTEMPTED TO CONTACT THE COMPLAINANT. BETWEEN 20APR2022 AND 02MAY2022, 3DM MADE THREE ATTEMPTS TO DISCUSS WITH THE COMPLAINANT WITH THE FINAL ATTEMPT RESULTING IN A MEETING SCHEDULED. THE COMPLAINANT WAS NOT ABLE TO ATTEND THE MEETINGS BUT ON 18MAY2022 THE SALES MANAGER SPOKE TO HER ABOUT THE INCIDENT AND THE BACKGROUND INFORMATION ABOUT THE EVENT WAS PROVIDED AT THAT TIME. ON 03MAY2022, 3DM BEGAN THE INSTALLATION PROCESS TO SUBMIT REPORTS ELECTRONICALLY. THE PROCESS WAS NOT VERIFIED AS COMPLETED UNTIL 01JUL2022 AND THE QUALITY AND REGULATORY MANAGER BEGAN WORKING ON THE REPORT AT THAT TIME.

    Description of Event or Problem · 0

    A DOCTOR REPORTED A PATIENT INVOLVED IN A SURGICAL PROCEDURE WITH PURASINUS REQUIRED HOSPITALIZATION DUE TO A RE-BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356351 PURASINUS PURASINUS NHB 3-D MATRIX, INC D651-005 21B16A30 00860001820836

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Prefer Not To Disclose Hospitalization NONE KNOWN