MAUDE Adverse Event Report: EBI, LLC. ELECTRODES, LT-4500; SOFT TOUCH ELECTRODES

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: unknown.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 sales rep that the patient stated that the she got a skin irritation on the lower back from lt-4500 electrodes.The irritation started in (b)(6).The skin is hot, bumpy red, itchy, blisters and oozy.The patient stated that it looks like a burn.The irritation was strictly under the electrodes.The electrodes were changed every other day.The patient stated that her doctor told her to change the position to across from each other.The area was cleaned with soap and water.No wipes.No new product.The patient called the doctor about the irritation.The doctor told the patient to contact the sales rep.New lt-4500 electrodes, electrode cover patches, 20" lead wires and 72r soft-touch electrodes were shipped to the patient.
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 d4, g3, 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 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.Highridge medical will continue to monitor for trend.
Event or Problem Description
It was reported by the sales rep that the patient stated that the she got a skin irritation on the lower back from lt-4500 electrodes.The irritation started in january.The skin is hot, bumpy red, itchy, blisters and oozy.The patient stated that it looks like a burn.The irritation was strictly under the electrodes.The electrodes were changed every other day.The patient stated that her doctor told her to change the position to across from each other.The area was cleaned with soap and water.No wipes.No new product.The patient called the doctor about the irritation.The doctor told the patient to contact the sales rep.No additional patient consequences have been reported.The lt-4500 electrodes were not returned for further evaluation.

• Brand Name: ELECTRODES, LT-4500
• Common Device Name: SOFT TOUCH 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: 11423646
• Report Number: 0002242816-2021-00022
• Device Sequence Number: 17270832
• Product Code: LOF
• UDI-Device Identifier: 00812301020188
• UDI-Public: 00812301020188
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/17/2024

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: 106130-12
• Device Lot Number: 916515
• 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: 02/08/2021
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2019
• 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