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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); 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) 2022.Concomitant medical product: unknown.Therapy date: unknown.The customer has returned the product to zimvie.The product evaluation is anticipated but has not yet begun.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported by the patient that her skin became irritated while using the 62b electrodes.The patient stated that she did not do the time test and used the same electrodes for 2 days in a row.The patient would take the electrodes off and put the same ones back on.Our customer service representative advised the patient to wait until her skin was completely healed then conduct a time test at 1-hour increments starting with the 63b electrodes.They also discussed changing the electrodes each day and changing the position of her skin.The patient was advised to call back if there are any issues during the time test.The patient stated that she stopped using the product on her own because of the allergic reaction to the electrodes.The patient made her doctor aware that she stopped using the product.The doctor did not prescribe any medication to her.The patient stated that she will talk to her doctor again and might try treatment again starting with 30-minute increments.The patient will return an example of the 63b electrodes and will follow up with them next week.The patient stated that she went to the emergency room last week for an unrelated issue and used the electrodes while there.The patient again broke out in a bad rash and the doctor told her to discontinue the use of the unit.The patient will still be returning an example of the electrodes.
Event or Problem Description
It was reported by the patient that her skin became irritated while using the 62b electrodes.The patient stated that she did not do the time test and used the same electrodes for 2 days in a row.The patient would take the electrodes off and put the same ones back on.Our customer service representative advised the patient to wait until her skin was completely healed then conduct a time test at 1-hour increments starting with the 63b electrodes.They also discussed changing the electrodes each day and changing the position of her skin.The patient was advised to call back if there are any issues during the time test.The patient stated that she stopped using the product on her own because of the allergic reaction to the electrodes.The patient made her doctor aware that she stopped using the product.The doctor did not prescribe any medication to her.The patient stated that she will talk to her doctor again and might try treatment again starting with 30-minute increments.The patient will return an example of the 63b electrodes and will follow up with them next week.The patient stated that she went to the emergency room last week for an unrelated issue and used the electrodes while there.The patient again broke out in a bad rash and the doctor told her to discontinue the use of the unit.The patient will still be returning an example of the electrodes.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation.The device history record was reviewed and no discrepancies related to the reported event were found.No physical and/or functional condition could be found after the dhr that could be considered a causal factor for the reported complaint.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly zimvie will continue to monitor for trends.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Common Device Name: ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15685591
• Report Number: 0002242816-2022-00126
• Device Sequence Number: 20420261
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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: N/A
• Device Catalogue Number: 106130-22
• Device Lot Number: 034301
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2020
• 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: Female