BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RLSND121-2.5

    MDR report key: 14654295 · Received June 10, 2022

    Report

    Report Number
    1067162-2022-00003
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    May 11, 2022
    Report Date
    June 10, 2022
    Manufacturer
    RHYTHMLINK INTERNATIONAL, LLC
    Product Code
    GXZ
    UDI-DI
    10816312020141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A TECHNICIAN REMOVED THE LEAD FROM THE PATIENT, THE NEEDLE WAS DETACHED FROM THE LEAD, AND THE NEEDLE REMAINED IN THE PATIENT'S SKIN. THE CUSTOMER STATED THE PRODUCT WAS RLSND121-2.5, BUT WAS UNSURE OF THE LOT NUMBER (PM00020288 OR PM00020061).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678417 RLSND121-2.5 SUBDERMAL NEEDLE ELECTRODE GXZ RHYTHMLINK INTERNATIONAL, LLC RLSND121-2.5 PM00020288 OR PM00020061 10816312020141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other