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

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2013.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the patient had more irritation after using the 63b electrodes.She is having to discontinue the use of the device per her dermatologist.If her spine surgeon determines she needs to restart the use of the device after her july appointment, she will use the 72r electrodes for a few hours a day.The patient explained the severity of the irritation with the 63b electrodes.The irritation began during the first week with the 63b electrodes.Her skin was itchy for about one week then her irritation spread all over her back and she had bumps and white bumps on her back.She saw her dermatologist who diagnosed her with irritant contact dermatitis, prescribed clobetasol propionate 0.05 cream, and asked her to discontinue the use of the electrodes.I asked the patient when she transitioned to the 63b electrodes if she completed the time test.The patient said she did not perform the time test with 63b electrodes.When she used the 63b electrodes the patient claims she changed to new electrodes every 2-3 days and rotated at that time.The patient cleaned her skin in the shower.The patient is allergic to penicillin, aleve, vioxx, celvane and gabapentin, combi patches.The patient reports her follow up with her surgeon in july and will follow up with us then.No further information has been reported at this time.
Event or Problem Description
It was reported that the patient had more irritation after using the 63b electrodes.She is having to discontinue the use of the device per her dermatologist.If her spine surgeon determines she needs to restart the use of the device after her july appointment, she will use the 72r electrodes for a few hours a day.The patient explained the severity of the irritation with the 63b electrodes.The irritation began during the first week with the 63b electrodes.Her skin was itchy for about one week then her irritation spread all over her back and she had bumps and white bumps on her back.She saw her dermatologist who diagnosed her with irritant contact dermatitis, prescribed clobetasol propionate 0.05 cream, and asked her to discontinue the use of the electrodes.I asked the patient when she transitioned to the 63b electrodes if she completed the time test.The patient said she did not perform the time test with 63b electrodes.When she used the 63b electrodes the patient claims she changed to new electrodes every 2-3 days and rotated at that time.The patient cleaned her skin in the shower.The patient is allergic to penicillin, aleve, vioxx, cevanes and gabapentin, combi patches.The patient reports her follow up with her surgeon in july and will follow up with us then.No further information has been reported at this time.
Additional Manufacturer Narrative
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.This complaint will be tracked and trended per sop 114.0.2 bht complaint trending procedure for any adverse trends that may warrant further action.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.

• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17139585
• Report Number: 0002242816-2023-00076
• Device Sequence Number: 12255274
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/13/2024

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: 135401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• 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
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic