BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEN20 CONDUCTIVE PASTE

    MDR report key: 6323829 · Received February 10, 2017

    Report

    Report Number
    1718791-2017-00001
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    September 22, 2016
    Report Date
    February 10, 2017
    Manufacturer
    D. O. WEAVER AND COMPANY
    Product Code
    GYB
    PMA / PMN Number
    K883149A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTED CONTACT WITH PATIENT ON FEB 3, 2017, FEB 7, 2017, AND FEB 9, 2017. PATIENT DID NOT ANSWER PHONE. VOICEMAIL LEFT ON FEB 3RD, BUT NOT RETURN CALL. COULD NOT LEAVE VOICEMAIL ON NEXT TWO ATTEMPTS DUE TO PATIENT'S VOICEMAIL BOX BEING FULL. IT IS A KNOWN FACT THAT A VERY SMALL PERCENTAGE OF THE POPULATION WILL REACT NEGATIVELY TO TOPICAL PRODUCTS. BASED ON THE INFORMATION PROVIDED, PATIENT MAY HAVE EXPERIENCED AN ALLERGIC REACTION TO TEN20. WITHOUT FURTHER INFORMATION, WE CANNOT DETERMINE A MORE DEFINITIVE CAUSE. IT ADDITIONAL INFORMATION BECOMES AVAILABLE, WE WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PT CALLED JAN 10, 2017 REGARDING AN INJURY SHE SUSTAINED DURING AN EEG THAT WAS PERFORMED ON HER ON (B)(6) 2016. FOLLOWING THE EEG, PT CLAIMS SHE WAS NOT ALLOWED TO WASH HER HAIR. AS A RESULT, SHE DEVELOPED AN ITCHY SCALP THAT LATER SPREAD DOWN THE BACK OF HER NECK AND ONTO HER SHOULDERS. SHE WAS TOLD THAT TEN20 WAS USED DURING HER EEG. SHE CONTACTED HER PHARMACIST, WHO PROVIDED HER WITH A LIST OF INGREDIENTS IN TEN20, BUT STATED THAT NONE OF THEM SHOULD DEVELOP A GENERAL AREA OF ITCHINESS. SHE MADE AN APPOINTMENT WITH HER PRIMARY CARE PHYSICIAN, WHICH TOOK PLACE (B)(6) 2017. WE TOLD HER WE WOULD CALL HER BACK AFTER HER APPOINTMENT TO ASCERTAIN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105969 TEN20 CONDUCTIVE PASTE NEURODIAGNOSTIC ELECTRODE PASTE GYB D. O. WEAVER AND COMPANY 10-20-XX

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other