BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TECHNOMED EUROPE

    MDR report key: 12811651 · Received November 15, 2021

    Report

    Report Number
    9710376-2021-00002
    Event Type
    Injury
    Date Received
    November 15, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 21, 2021
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375861547
    PMA / PMN Number
    K130136
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP. THIS IS A FINAL REPORT (FOLLOW-UP NUMBER 1), INITIAL REPORT NUMBER: 9710376-2021-00002.

    Description of Event or Problem · 0

    THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.

    Description of Event or Problem · 0

    THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.

    Description of Event or Problem · 0

    THE CORKSCREW ELECTRODE WAS INSERTED INTO A PATIENT'S SCALP, WAS REMOVED, AND SUBSEQUENTLY REPOSITIONED IN ANOTHER POSITION IN THE PATIENT'S SCALP. UPON SCREWING THE ELECTRODE BACK IN, THE HEALTH PROFESSIONAL NOTICED THAT IT WAS SCREWING BUT NOT STOPPING (INDICATES IT IS IN), TOOK HER HAND AWAY TO CHECK IF IT WAS IN, AND THE PLASTIC CAP AND CORD CAME AWAY WITH NO NEEDLE INSIDE. THE HEALTH PROFESSIONAL OBSERVED THAT THE NEEDLE ELECTRODE WAS STILL LODGED IN THE PATIENT'S SCALP. THEREAFTER, ATTEMPTS WERE MADE TO REMOVE THE NEEDLE ELECTRODE WITH FORCEPS, BUT EVENTUALLY A SMALL INCISION HAD TO BE MADE IN ORDER TO BE ABLE TO REMOVE THE NEEDLE ELECTRODE FROM THE SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711050 TECHNOMED EUROPE DISPOSABLE SUBDERMAL NEEDLE ELECTRODE, CORKSCREW GXZ TECHNOMED EUROPE TE/S50715-001 049662 08718375861547

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other