BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUPREP SKIN PREP GEL

    MDR report key: 19084450 · Received April 10, 2024

    Report

    Report Number
    1718791-2024-24002
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 13, 2024
    Report Date
    April 8, 2024
    Manufacturer
    D.O. WEAVER AND COMPANY
    Product Code
    DRX
    PMA / PMN Number
    K885306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER COMMUNICATION, WEAVER REQUESTED DETAILS ABOUT THE APPLICATION METHOD USED WITH BIOSERENITY'S ICECAP2 PRODUCT. BIOSERENITY PROVIDED THEIR IFU/PROCEDURE ISSUED TO TECHNICIANS, HIGHLIGHTING SAFETY CONSIDERATIONS FOR ICECAP2 USE. HOWEVER, IT OMITS GUIDANCE ON THE SAFE AND EFFECTIVE HANDLING OF ANCILLARY PRODUCTS NECESSARY FOR ICECAP2 OPERATION. THIS OVERSIGHT COULD RESULT IN TECHNICIAN MISUSE OF MEDICAL DEVICES ESSENTIAL FOR THE ICECAP2'S PROPER FUNCTIONING. WEAVER RECOMMENDED THAT BIOSERENITY REVISE THEIR PROCEDURES TO EXPLICITLY ADDRESS SAFETY CONCERNS RELATED TO ALL DEVICES USED IN CONJUNCTION WITH ICECAP2. ADDITIONALLY, WEAVER SHARED BEST PRACTICES FOR SKIN SAFETY, EMPHASIZING THE IMPORTANCE OF PROPER PREPARATION AND MONITORING IN LONG-TERM EEG STUDIES. WHILE MULTIPLE FACTORS CONTRIBUTED TO THE PATIENT'S INJURY, ADHERENCE TO THE IFU FOR ALL PRODUCTS INVOLVED IN THE AMBULATORY MONITORING PROCEDURE MAY HAVE MITIGATED THE SEVERITY OR PREVENTED THE INCIDENT.

    Description of Event or Problem · 0

    WEAVER AND COMPANY WAS CONTACTED ON (B)(6) 2024 VIA EMAIL REGARDING SKIN IRRITATION. AFTER FURTHER CORRESPONDENCE, ON 03/13/2024 WEAVER AND COMPANY BECAME AWARE THAT AN ADVERSE EVENT HAD OCCURED IN FRANCE. BIOSERENITY A PATIENT FACILITY AND MANUFACTURER OF ICECAPS, AN ELECTRODE ARRAY CAP USED FOR EEG MONITORING, INFORMED US THAT A PATIENT EXPERIENCED SEVERE SKIN IRRITATION FOLLOWING A 72-HOUR AMBULATORY EEG SESSION.THE PATIENT EXPERIENCED SKIN IRRITATION AT THE FP1 AND FP2 ELECTRODE SITES OF THE FOREHEAD. WEAVER SENT SEVERAL FOLLOW UP EMAILS TO GATHER INFORMATION REGARDING THE EVENT, THE METHOD OF USE, LOT NUMNBERS, AND INFORMATION REGARDING ANY OTHER PRODUCTS OR PRACTICES THAT MAY HAVE CONTRIBUTED TO THE INJURY. WEAVER WAS INFORMED THAT NUPREP SKIN PREP GEL WAS USED TO PREP THE SKIN, TEN 20 CONDUCTIVE PASTE WAS USED TO SECURE THE ELECTRODES, AN ICECAP WAS USED AS THE ELECTRODES, FINALLY SAC2 CREME MANUFACTURED BY SPES MEDICA WAS USED TO FURTHER SECURE THE ICECAP TO THE PATIENTS SKIN. THE REPORTER DID NOT HAVE RECORDS OF THE LOT NUMBERS INVOLVED IN THE INCIDENT OR IF A SKIN SENSITIVITY TEST WAS COMPLETED. THE REPORTER INFORMED US THAT THE PATIENT HAD NO MEDICAL HISTORY OF ALLERGIES. THE SKIN IRRITATION REQUIRED EMERGENCY MEDICAL INTERVENTION WITH CORTICOSTEROIDS AND ANTIHISTAMINES. THE PATIENT MADE A FULL RECOVERY WITH NO SCARRING. THIS PATIENT, WAS PART OF A LONG-TERM STUDY FACILITATED BY BIOSERENITY, WHERE A TECHNICIAN SETS UP EEG EQUIPMENT FOR AT HOME MONITORING, USING THE ICECAP. A TECHNICIAN THEN REMOTELY MONITORS THE STUDY. THIS METHOD HINDERS THE TECHNICIANS ABILITY TO PERFORM REGULAR CHECKS OF THE ELECTRODE SITES, AS RECOMMENDED BY OUR INSTRUCTIONS FOR USE. THER REPORTER INFORMED US THAT THESE PERIODIC CHECKS ARE NOT PERFORMED DUE TO THE NATURE OF THEIR MEDICAL DEVICE AND THEIR METHOD OF REMOTE MONITORING. WEAVER INFORMED THE REPORTER THAT OUR IFU STATES "LONG TERM ELECTRODE SITES MUST BE CHECKED FOR IRRITATION AND REDNESS AT LEAST DAILY BY REMOVING THE ELECTRODE AND EVALUATING THE SKIN CONDITION UNDER THE ELECTRODE." IN ADDITION THE IFU STATES "PATIENTS' TOLERANCE FOR TOPICAL PRODUCTS VARIES WIDELY. SOME PATIENTS POORLY TOLERATE ADHESIVES, ABRASIVES, CONDUCTIVE MEDIA, AND SALTS. RESPOND TO ANY COMPLAINT THAT MAY SIGNAL PRODUCT INTOLERANCE. INSTRUCT PATIENTS TO COMMUNICATE ANY PERSISTENT REDNESS, SORENESS OR SWELLING AT THE ELECTRODE SITE." WEAVER EXPRESSED UNDERSTANDING OF THE CONSTRAINTS AROUND PERIODIC CHECKS OF THE ELECTRODE SITES BUT EMPHASIZED THE IMPORTANCE OF FOLLOWING THE INSTRUCTIONS FOR USE FOR PATIENT SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125957 NUPREP SKIN PREP GEL SKIN PREP GEL DRX D.O. WEAVER AND COMPANY 10-30 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other ICECAP2 MANUFACTURED BY BIOSERENITY SAS| SAC2 CREME MANUFACTURED BY SPES MEDICA S.R.L