BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK 20" LEAD WIRES

    MDR report key: 6120819 · Received November 22, 2016

    Report

    Report Number
    0002242816-2016-00038
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    November 1, 2016
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PMA#: P850022/S017. THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION BY THE PATIENT. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. THE PATIENT ADVISED SHE HAS MONO AND WAS TAKING ANTIBIOTICS BEFORE THE BUMPS APPEARED. THE PATIENT ADVISED THE EMERGENCY ROOM STAFF BELIEVES THE PATIENT WAS SUFFERING FROM AN ALLERGIC REACTION TO THE ANTIBIOTIC MEDICATION SHE WAS TAKING FOR MONO. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE RECEIVED THE SPINALPAK THREE WEEKS PRIOR TO (B)(6) 2016. THE PATIENT REPORTED EXPERIENCING RED BUMPS WHERE THE LEAD WIRE RUNS UP HER NECK AS WELL AS ELSEWHERE ON HER BODY. THE PATIENT ADVISED SHE HAS MONO AND WAS TAKING ANTIBIOTICS BEFORE THE BUMPS APPEARED. THE PATIENT ADVISED SHE WENT TO THE EMERGENCY ROOM ON (B)(6) 2016 WHERE SHE WAS GIVEN BENADRYL. THE PATIENT STATED THE MEDICATION ALLOWED HER TO SLEEP. BUT, THE NEXT DAY HER SYMPTOMS HAD WORSENED AND SHE HAD TO GO BACK TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN STEROIDS AND HYDROXYZINE. THE PATIENT ADVISED THE EMERGENCY ROOM STAFF BELIEVES THE PATIENT WAS SUFFERING FROM AN ALLERGIC REACTION TO THE ANTIBIOTIC MEDICATION SHE WAS TAKING FOR MONO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773596 SPINALPAK 20" LEAD WIRES LEAD WIRES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention