MAUDE Adverse Event Report: EBI, LLC. ELECTRODE COVER PATCHES; ELECTRODES COVER PATCHES

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rash (2033); Blister (4537)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Date of event: the event occurred sometime in september 2022.Concomitant medical products: 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 by the patient that the 63b electrodes also caused irritation even with the timed test.The patient stated that he wore for 4-5 hours and is getting rashes again.The patient stated that his skin was completely healed be he started treatment with the 63b electrodes and he is having rashes on both left and right sides of his feet.The patient also stated that he is getting tiny bubbles (welts) that are itchy.The patient was advised to call the doctor and tell them that both 72r/63b electrodes caused irritation and to call us back with an update.The patient also stated that the rash was under the cover patches as well, whereas with the 72rs it was only under the electrodes.It was reported the patient's doctor requested the patient be switched to the bhs unit due to the rash with the orthopak.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The device was not returned to (b)(6) medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record/ certificate of conformance was reviewed, and no discrepancies related to the reported event were found.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.(b)(6) medical will continue to monitor for trend.
Event or Problem Description
It was reported by the patient that the 63b electrodes caused irritation even with the timed test.The patient stated that he wore for 4-5 hours and is getting rashes again.The patient stated that his skin was completely healed before he started treatment with the 63b electrodes.He is having rashes on both left and right sides of his feet.The patient also stated that he is getting tiny bubbles (welts) that are itchy.The patient was advised to call the doctor and tell them that both 72r/63b electrodes caused irritation and to call us back with an update.The patient also stated that the rash was under the cover patches as well, whereas with the 72rs it was only under the electrodes.It was reported the patient's doctor requested the patient be switched to the bhs unit due to the rash with the orthopak.No additional patient consequences have been reported.No additional patient consequences have been reported.63b electrodes were not returned for evaluation.

• Brand Name: ELECTRODE COVER PATCHES
• Common Device Name: ELECTRODES COVER PATCHES
• 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: 15547411
• Report Number: 0002242816-2022-00115
• Device Sequence Number: 13901451
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/22/2024

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: 106130-17
• Device Lot Number: 131204
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2021
• 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; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic