BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EC2 CREAM

    MDR report key: 7910140 · Received September 26, 2018

    Report

    Report Number
    3005581270-2018-00012
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 13, 2018
    Report Date
    October 24, 2018
    Manufacturer
    NATUS MANUFACTURING LTD
    Product Code
    GYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT MADE A REPORT THROUGH FDA MEDWATCH AND REPORTED AN ALLERGIC REACTION POST A 3 DAY AMBULATORY EEG STUDY. IT IS ALLEGED THAT THE ALLERGIC REACTION RESULTED FROM THE GLUE OR PASTE THAT WAS USED TO ATTACH THE ELECTRODES. EC2 CREAM (NATUS PART) WAS REFERENCED IN THE REPORT. THE VP OF MEDICAL AFFAIRS QARA AND LEGAL COUNCIL WERE NOTIFIED AS PER QMS-000039 SECTIONS 5.1.6 AND 6.3.11. CUSTOMER WAS CONTACTED VIA EMAIL BY NATUS COMPLAINT ANALYST TO GET MORE INFORMATION ON THE MATTER AND A QUESTIONNAIRE WAS COMPLETED. THE CLINIC WHERE THE PATIENT UNDERWENT THE STUDY WAS CONTACTED AND WE RECEIVED THE ANSWERS TO THE QUESTIONAIRE; IT WAS NOTED THAT THE PATIENT DID NOT CONTACT THE THEM DURING THE 72 HR EEG, HE CALLED LATER IN THE DAY TO SAY IT WAS PAINFUL. HE WAS ADVISED TO CONTACT HIS PRIMARY CARE UNIT. WHEN HE WAS CONTACTED A FEW DAYS LATER HE RECEIVED A ANTIBIOTIC FROM HIS PHYSICIAN. WHEN HE CAME IN ON THE (B)(6) 2018 THE WELTS WERE GONE. THERE WAS NO LOT NUMBERS RECORDED AND THAT PARTICULAR TUBE WAS THROWN AWAY ON THE SAME DAY OF USE. NO INFORMATION ON THE PRODUCT USED OR LOT/SERIAL NUMBER INFORMATION WAS PROVIDED THEREFORE A DHR REVIEW CANNOT BE COMPLETED AT THIS TIME. A RISK REVIEW WAS COMPLETED FOR THIS ISSUE. HAZARD ID 5 FROM (B)(4) RISK MANAGEMENT PLAN WAS SELECTED. POTENTIAL HAZARD: ALLERGEN, HAZARDOUS SITUATION: PATIENT ALLERGIC REACTION TO ONE OR MORE CONSTITUENTS OF THE EC2 ELECTRODE CREAM, HARM: PATIENT MAY DEVELOP SKIN RASH AFTER PROCEDURE. THE RISK RATING OF THIS HAZARD IS LOW (SEVERITY OF 1, PROBABILITY OF OCCURRENCE A). A REVIEW OF COMPLAINTS HAS BEEN COMPLETED AND THERE HAVE BEEN NO OTHER COMPLAINTS IN THE LAST 12 MONTHS FOR EC2 CREAM, NO SYSTEMIC ISSUE AT THIS TIME, THEREFORE RISK RATING DOES NOT REQUIRE UPDATING AT THIS TIME. BIOCOMPATIBILITY STUDIES WERE COMPLETED AS PART OF THE DESIGN OF THE PRODUCT AND BIOCOMPATIBILITY OF EC2 WAS DECLARED. REVIEW OF THE INGREDIENTS WAS COMPLETED AND THEIR FUNCTIONS ARE DOCUMENTED. MATERIAL SAFETY DATA SHEET FOR EC2 CREAM WAS ALSO OBTAINED. THERE ARE NO HAZARDOUS COMPONENTS, PRODUCT DOES NOT CONTAIN ANY NICKEL, LATEX OR SILICONE. THERE ARE NO HEALTH HAZARDS ASSOCIATED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED FROM THE PATIENT WHO WAS THE INITIAL REPORTER OF THIS ADVERSE EVENT. THE FACILITY NAME WAS PROVIDED AND NATUS ATTEMPTED TO CONTACT THIS FACILITY ON NUMEROUS OCCASIONS THROUGH PHONE FOR FURTHER INFORMATION (PART NUMBER / LOT NUMBER ETC.). NO RESPONSE TO ANY OF NATUS VOICEMAILS WERE RECEIVED. JUSTIFICATION FOR NOT PROVIDING BELOW INFORMATION AND APPLICABLE SECTIONS: RELEVANT TESTS / LABORATORY DATA - THE PATIENT WAS ASKED THIS QUESTION BUT DID NOT PROVIDE THIS INFORMATION. NATUS HAS ATTEMPTED TO CONTACT THE FACILITY ON NUMEROUS OCCASIONS BUT NO RESPONSE HAS BEEN RECEIVED. SUSPECT PRODUCTS - NOT APPLICABLE. MODEL #, CATALOG #, LOT#, EXPIRATION DATE, UNIQUE IDENTIFIER - DEFECT PART NUMBER AND LOT NUMBER REQUESTED FROM THE PATIENT BUT THIS INFORMATION WAS NOT AVAILABLE TO THE PATIENT. NATUS HAS ATTEMPTED TO CONTACT THE FACILITY ON NUMEROUS OCCASIONS BUT NO RESPONSE HAS BEEN RECEIVED. SERIAL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE DOES NOT HAVE A SERIAL NUMBER. IF IMPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. IF EXPLANTED DATE (MM/DD/YYYY) - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IMPLANTABLE. REPROCESSOR NAME AND ADDRESS - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT A SINGLE-USE DEVICE THAT WAS REPROCESSED OR REUSED ON A PATIENT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDING TREATMENT OF EVENT) - THIS SECTION IS NOT APPLICABLE TO THIS TYPE OF DEVICE. INITIAL REPORTER - INITIAL REPORTER IN THIS CASE WAS THE PATIENT. NO INFORMATION ON THE PATIENTS ADDRESS. THE FACILITY ESTABLISHMENT ADDRESS IS AS FOLLOWS: (B)(6). FOR USE BY USER FACILITY / IMPORTER - NOT APPLICABLE AS WE ARE NOT A FACILITY OR IMPORTER OF DEVICE. PMS/510(K) - NOT APPLICABLE - PRE-AMENDMENT. IF ND, GIVE PROTOCOL # - THIS SECTION IS NOT APPLICABLE AS THE MEDICAL DEVICE IS NOT IND. ADVERSE EVENT TERMS - THIS SECTION IS NOT APPLICABLE TO MEDICAL DEVICES. DEVICE MANUFACTURE DATE - UNKNOWN DEVICE LOT NUMBER TO DETERMINE MANUFACTURE DATE IF REMEDIAL ACTION INITIATED , CHECK TYPE - THIS SECTION IS NOT APPLICABLE AS NO REMEDIAL ACTION WAS INITIATED. IF ACTION REPORTED TO FDA UNDER 21 USC 360I (F), LIST CORRECTION / REMOVAL REPORTING NUMBER - THIS SECTION IS NOT APPLICABLE AS THERE WAS NO ACTION REPORTED UNDER 21 USC 360I(F).

    Description of Event or Problem · 1

    ALLERGIC REACTION TO EC2 CREAM. DURING A 3 DAY AMBULATORY EEG, THE PATIENT HAD ELECTRODES PLACED ONTO HIM. THE PATIENT FELT A THROBBING, A BIT OF AN ITCH AND SLIGHT PAIN BUT WAS TOLD THIS WAS NORMAL. THE THROBBING WAS NOT PAINFUL, JUST A THROBBING SENSATION. THROUGHOUT THE WEEKEND THE PATIENTS HEAD ITCHED AND HE HAD SOME SLIGHT PAIN. ON REMOVAL OF THE EEG ELECTRODES, IT WAS NOTICED THAT THERE WAS A SERIOUS ALLERGIC REACTION. VERY NASTY RED SPOTS ON THE PATIENTS FOREHEAD AND TOP OF THE HEAD. THE CLINIC STATED THAT THIS COULD ONLY BE CAUSED BY THE GLUE OR PASTE USED DURING THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750590 EC2 CREAM EC2® GENUINE GRASS ELECTRODE CREAM GYB NATUS MANUFACTURING LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other