MAUDE Adverse Event Report: D.O. WEAVER AND COMPANY TEN20 CONDUCTIVE PASTE; ELECTROCONDUCTIVE ADHESIVE PASTE

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Weaver and company was contacted on 02/14/2024 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 numbers, 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, ten20 conductive paste was used to secure the electodes, 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 contraints around periodic checks of the electrode sites but emphasized the importance of following the instructions for use for patient safety.

Manufacturer Narrative

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.

• Brand Name: TEN20 CONDUCTIVE PASTE
• Type of Device: ELECTROCONDUCTIVE ADHESIVE PASTE
• Manufacturer (Section D): D.O. WEAVER AND COMPANY; 565 nucla way; unit b; aurora CO 80011
• Manufacturer (Section G): D.O. WEAVER AND COMPANY; 565 nucla way; unit b; aurora CO 80011
• Manufacturer Contact: daniel pincus ; 565 nucla way; unit b; aurora, CO 80011 ; 7203431627
• MDR Report Key: 19084042
• MDR Text Key: 339877162
• Report Number: 1718791-2024-24001
• Device Sequence Number: 1
• Product Code: GYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K883149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ICECAP2 MANUFACTURED BY BIOSERENITY SAS; SAC2 CREME MANUFACTURED BY SPES MEDICA S.R.L
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White