BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NALU NEUROSTIMULATION SYSTEM

    MDR report key: 14324120 · Received May 7, 2022

    Report

    Report Number
    3015425075-2022-00029
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    February 17, 2022
    Report Date
    May 6, 2022
    Manufacturer
    NALU MEDICAL INC
    Product Code
    GZF
    PMA / PMN Number
    K183579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTS INCISION OPENED WHEN THE PATIENT CROSSED LEGS. SUBSEQUENT FOLLOW UP WITH PHYSICIAN ON (B)(6) 2022 REVEALED POSSIBLE INFECTION. PHYSICIAN PRESCRIBED A NEW ANTIBIOTIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949417 NALU NEUROSTIMULATION SYSTEM PERIPHERAL NERVE STIMULATOR GZF NALU MEDICAL INC 72007 KX346 / P5207

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other