MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B; 63B ELECTRODES

Model Number	106130-20
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).B3: date of event: the event occurred sometime on (b)(6) 2023.D11: medical product: unknown d11: therapy date: unknown the device will not be returned for analysis; however, an investigation of the reported.Event is in progress.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported by the patient that the 72r electrodes caused an irritation on her skin.The patient wore the electrodes for 2-3 days.The patient called the doctor and was told to call zimvie.The patient stated that the irritation has gotten better since changing them every day.The patient was advised to stop wearing the electrodes and to let her skin heal and try the 63b electrodes.63b electrodes have been sent to the patient.There is no product to return.It was reported by the patient that the 63b electrodes are also irritating her skin as well.The patient stated that she did not do the time test when she switched electrodes.The patient stated that she treats for 12 hours and rests the skin for 12 hours.The patient washes the skin with warm water and uses hydrocortisone cream in between.The patient did not speak to her doctor about the irritation because she has always had sensitive skin.The patient's skin was red, itchy and had blisters.The patient wants to go back to using the 72r electrodes as the irritation wasn't as bad with them.The patient will perform the time test for 2 days at each stage and report back if there are any issues.The 72r electrodes and usps pouch have been sent to the patient.It was reported by the patient that every single electrode that she has used has caused a skin irritation.The patient spoke to her doctor and was told to discontinue using the electrodes.The doctor did not prescribe anything.The patient was using hydrocortisone cream over the counter.The only thing that helped the patient was not using the electrodes.The patient used the unit for as long as possible.The patient had red skin, itchiness, a rash and significant contact dermatitis.The patient also had open wounds from scratching.The patient did not take any pictures from the skin irritation.The patient will be sending one pack of each electrode she has used.
Additional Manufacturer Narrative
Corrections - a: dob, b4: date of this report added, b5: event description, d2: common device name, d3: manufacturer address and email address, d4: catalog number and udi, g1: contact office and manufacturer site, g6: report type additional information - d4: lot number, d9: device available for evaluation and date returned to manufacturer, g3, h4: device manufacture date, h6: impact code, method, results, and conclusions, h10: additional narrative, h11 review of the information provided by the customer and along with findings from the investigation, indicate there are no systemic issues with the product or lot.Therefore, the bill of materials (boms), material certifications, master labels, and product drawings were not requested or pulled during this investigation.The approved suppliers were not contacted, and the product was not pulled from stock for evaluation.No physical and/or functional condition could be found after review of the certificate of conformance that could be considered a causal factor for the reported complaint.The reported claim could be associated with a side effect/clinical condition of the patient which is unknown.The reported condition is related to clinical factors beyond the scope of the device investigation covered in the complaint investigation as part of the manufacturing review.Issue evaluation ie-00840 was initiated to investigate the received complaints of irritation/rash developed from the electrodes/cover patches.Hhed-10-2017-001 evaluated the risk to the patient.Therefore, no further actions are required at this time.Highridge medical will continue to monitor for trends.This device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported by the patient that the 72r electrodes caused an irritation on her skin.The patient wore the electrodes for 2-3 days.The patient called the doctor and was told to call (b)(6).The patient stated that the irritation has gotten better since changing them every day.The patient was advised to stop wearing the electrodes and to let her skin heal and try the 63b electrodes.63b electrodes have been sent to the patient.There is no product to return.It was reported by the patient that the 63b electrodes are also irritating her skin as well.The patient stated that she did not do the time test when she switched electrodes.The patient stated that she treats for 12 hours and rests the skin for 12 hours.The patient washes the skin with warm water and uses hydrocortisone cream in between.The patient did not speak to her doctor about the irritation because she has always had sensitive skin.The patient's skin was red, itchy and had blisters.The patient wants to go back to using the 72r electrodes as the irritation wasn't as bad with them.The patient will perform the time test for 2 days at each stage and report back if there are any issues.The 72r electrodes and usps pouch have been sent to the patient.It was reported by the patient that every single electrode that she has used has caused a skin irritation.The patient spoke to her doctor and was told to discontinue using the electrodes.The doctor did not prescribe anything.The patient was using hydrocortisone cream over the counter.The only thing that helped the patient was not using the electrodes.The patient used the unit for as long as possible.The patient had red skin, itchiness, a rash and significant contact dermatitis.The patient also had open wounds from scratching.The patient did not take any pictures from the skin irritation.The patient will be sending one pack of each electrode she has used.The 63b electrodes were returned for evaluation.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Common Device Name: 63B ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17351632
• Report Number: 0002242816-2023-00080
• Device Sequence Number: 17673269
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 106130-20
• Device Catalogue Number: 106130-22
• Device Lot Number: 132301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic