BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNAGEL

    MDR report key: 9342304 · Received November 19, 2019

    Report

    Report Number
    2212018-2019-00001
    Event Type
    Injury
    Date Received
    November 19, 2019
    Date of Event
    September 28, 2019
    Report Date
    October 4, 2019
    Manufacturer
    PARKER LABORATORIES, INC
    Product Code
    GYB
    UDI-DI
    20855683006214
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A TECHNICAL DATA SHEET WAS PROVIDED TO THE RESEARCHER AT THE TIME THE EVENT WAS REPORTED. THE TDS INCLUDES A REFERENCE TO THE PRESERVATIVE PARABENS. THE INSTRUCTIONS FOR USE INCLUDE A WARNING THAT SIGNAGEL SHOULD NOT BE USED ON PATIENTS WITH A KNOWN SENSITIVITY TO PARABENS; HOWEVER, IT IS NOTED THAT THE PATIENT DID NOT REPORT A SENSITIVITY TO PARABENS. NAUSEA AND SWELLING ARE NOT TYPICALLY ASSOCIATED WITH ALLERGIC REACTIONS THAT MAY OCCUR AS A RESULT OF USE OF THE GEL. TYPICALLY, A PATIENT WITH AN ALLERGIC RESPONSE WOULD EXPERIENCE ITCHING AND REDNESS AT THE APPLICATION SITE. AS A RESULT, PARKER FORWARDED A DESCRIPTION OF THE EVENT TO BIOSEMI, THE MANUFACTURER OF THE ELECTRODE SYSTEM, WHO ADVISED THAT THEY HAVE NOT RECEIVED ANY RELATED REPORTS FOR THEIR SYSTEM. BECAUSE THE LOT NUMBER IS NOT KNOWN, THE MANUFACTURING RECORDS AND RETAINED SAMPLES FOR THE LOT CANNOT BE REVIEWED. WE HAVE NOT RECEIVED ANY RELATED REPORTS OF HEAD SWELLING OR NAUSEA RESULTING FROM USE OF THIS GEL. THEREFORE WE CANNOT CONFIRM THAT THE GEL CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    ON OCTOBER 4, 2019, PARKER LABORATORIES WAS CONTACTED BY A POSTDOCTORAL RESEARCHER CONDUCTING A STUDY WHO REPORTED THAT AFTER USING SIGNAGEL ELECTRODE GEL ON A PARTICIPANT DURING EEG MEASUREMENTS, THE PARTICIPANT EXPERIENCED AN ALLERGIC REACTION ON THE HEAD (SWOLLEN HEAD AND NAUSEA). THE RESEARCHER ADVISED THIS WAS THE FIRST TIME HE OR ANY OF THE OTHER RESEARCHERS HAD RECEIVED A REPORT OF THIS NATURE INVOLVING THE GEL. PARKER FOLLOWED UP FOR ADDITIONAL DETAILS OF THE EVENT. THE GEL APPEARED TO HAVE NORMAL COLOR, ODOR, AND APPEARANCE AT THE TIME OF APPLICATION. THE RESEARCHER ADVISED THAT HE DOES NOT HAVE THE LOT NUMBER OF THE PRODUCT INVOLVED IN THE EVENT, AS IT HAD ALREADY BEEN DISCARDED BY THE CLEANING STAFF. THE PARTICIPANT IS A (B)(6) FEMALE; THE WEIGHT IS UNKNOWN. PREVIOUSLY KNOWN ALLERGIES FOR THE PATIENT INCLUDE CHEMICALS IN HAIR PAINTS. THIS WAS THE FIRST TIME THE PATIENT HAD BEEN EXPOSED TO SIGNAGEL. ON OCTOBER 8, 2019, THE RESEARCHER PROVIDED AN UPDATE THAT THE PARTICIPANT HAD ELECTED TO GO TO A HOSPITAL FOR MEDICATION AND THEIR CONDITION HAD RESOLVED. HE ALSO ADVISED THAT THE STUDY WAS CONDUCTED USING A BIOSEMI ELECTRODE SYSTEM. PARKER FOLLOWED UP FOR DETAILS OF THE PATIENT'S DIAGNOSIS AND TREATMENT. ON OCTOBER 14, 2019, THE RESEARCHER ADVISED THAT THE PARTICIPANT HAD RECEIVED ANTI-ALLERGIC TABLETS (TAVEGIL) AND AN ANTI ALLERGIC INJECTION. DESPITE SEVERAL FOLLOW UP ATTEMPTS, THE RESEARCHER HAS BEEN UNABLE TO PROVIDE ADDITIONAL INFORMATION RELATED TO THE INJECTION. HE DID ADVISE THAT THE PARTICIPANT DID NOT EXPERIENCE ANY REDNESS OR ITCHING AT THE APPLICATION SITE WHILE THEY WERE IN THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138292 SIGNAGEL ELECTRODE GEL GYB PARKER LABORATORIES, INC 15-25 UNKNOWN 20855683006214

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention