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

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Date of event: this event occurred sometime in (b)(6) 2020.Medical product: spinalpak assembly catalog: #1067716 serial: #(b)(4).Therapy date: unknown.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00036.
Event or Problem Description
It was reported that the patient developed skin irritation from the lt-4500 and 72r electrodes.The patient was applying the electrodes to the lumbar region of her spine.The patient described her skin as red and itchy with blisters, welts, and small bumps.The patient stopped using the device for four days.The patient stated that the skin developed scabs and it is scarring.The patient is using an over the counter medication to treat the skin irritation.The patient did call her doctor and the doctor advised the patient to wear the electrodes only at night.The patient says that the skin irritation has lessened since breaking up the treatment time.It was reported that no further information is available.
Event or Problem Description
It was reported that the patient developed skin irritation from the lt-4500 and 72r electrodes.The patient was applying the electrodes to the lumbar region of her spine.The patient described her skin as red and itchy with blisters, welts, and small bumps.The patient stopped using the device for four days.The patient stated that the skin developed scabs and it is scarring.The patient is using an over the counter medication to treat the skin irritation.The patient did call her doctor and the doctor advised the patient to wear the electrodes only at night.The patient says that the skin irritation has lessened since breaking up the treatment time.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow up report is being submitted to relay additional information.The device was returned to zimmer biomet 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.Zimmer biomet will continue to monitor for trends.The following sections were updated: b4: date of this report added.D10: device availability added.G4: date received by manufacturer added.G7: type of report.H2: follow up types.H3: device evaluated by manufacturer updated to yes.H4: device manufacturer date added.H6: method code updated to 3331: analysis of production records.H6: results code updated to 3221: no findings available.H6: conclusions code updated to 4315: cause not established.H10: additional narratives/data.

• Brand Name: ELECTRODES, LT-4500
• Common Device Name: ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• MDR Report Key: 9987353
• Report Number: 0002242816-2020-00035
• Device Sequence Number: 17068688
• Product Code: LOF
• UDI-Device Identifier: 00812301020188
• UDI-Public: 00812301020188
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2020

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: 106130-12
• Device Lot Number: 916515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 07/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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