BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHOMARK LP

    MDR report key: 11646251 · Received April 9, 2021

    Report

    Report Number
    3014680735-2021-00001
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    February 13, 2020
    Report Date
    February 11, 2021
    Manufacturer
    SONAVEX INC.
    Product Code
    NEU
    UDI-DI
    B53620001
    PMA / PMN Number
    K180621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMUNICATION INITIALLY RECEIVED STATED THE DEVICE WAS UNRELATED TO THE EVENT. NEW INFORMATION RECEIVED FROM INVESTIGATOR ON 1/28/2021 INDICATED POSSIBLE DEVICE INVOLVEMENT.

    Description of Event or Problem · 1

    TWO WEEKS POST-OP PATIENT REPORTED PAIN AND CLEAR FLUID DRAINAGE. PAIN MEDICATION AND PROPHYLACTIC ANTIBIOTICS PRESCRIBED. ELECTIVE SURGICAL RE-EXPLORATION PERFORMED ON (B)(6) 2020. IMPLANT EXPLANTED, CLEAR SEROUS FLUID DRAINED, NO GROSS EVIDENCE OF INFECTION OBSERVED. INITIALLY REPORTED AS POSSIBLE INFECTION AND UNRELATED TO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542623 ECHOMARK LP IMPLANTABLE RADIOGRAPHIC MARKER NEU SONAVEX INC. 2000 P-14526 B53620001

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention