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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient sometimes gets an allergic reaction when she is under the sun for too long.The patient had a skin irritation during the time test after 5 hours.The patient will start using the 63b electrodes in 4-hour intervals with no cover patches.63b electrodes have been sent to the patient.The product is not expected to be returned.The patient contacted her and stated that she began using the device for 5 consecutive hours and she had a rash, she visited her primary care physician and was prescribed atarax 25 mg so she used it this time and as per (b)(6) the area is now healed.No further consequences were reported.
Additional Manufacturer Narrative
Zimvie complaint (b)(4).B3: date of event: the event occurred sometime in (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.
Additional Manufacturer Narrative
Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record related to the reported event was not reviewed as neither the lot number or serial number were known.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported that the patient sometimes she gets an allergic reaction when she is under the sun for too long.The patient had a skin irritation during the time test after 5 hours.The patient will start using the 63b electrodes in 4-hour intervals with no cover patches.63b electrodes have been sent to the patient.The product is not expected to be returned.The patient contacted her and stated that she began using the device for 5 consecutive hours and she had a rash, she visited her primary care physician and was prescribed atarax 25 mg so she used it this time and as per eva the area is now healed.No further consequences were reported.No additional patient consequences have been reported.63b electrodes were not returned for further evaluations.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Common Device Name: 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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 16911119
• Report Number: 0002242816-2023-00042
• Device Sequence Number: 12625402
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 106130-22
• Device Lot Number: 214704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 05/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic