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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.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 Description

It was reported by the patient's wife the electrode covers "make him itchy".The patient's wife confirmed that it was the covers and not the electrodes themselves.The sales representative recommended that the patient should discontinue the use of the electrode covers and just use the electrodes.Zimvie customer service contacted the patient regarding the cover patches.The patient's wife stated that the cover patches are causing the skin to itch and become red.The patient's wife described the skin getting bumpy.The patient also had skin irritation from surgical tape at that time.The doctor prescribed a cream for the skin irritation.The patient¿s wife stated that she is using the same cream for the cover patches, but she does not have the name with her.The patient was sent replacement 72r electrodes.It was later reported on aug 19, 2022, that the patient's wife stated that her husband has a little irritation from the cover patches, his skin just gets a little red.She stated that the doctor has prescribed a salve for the irritation and the patient continues to treat with the unit.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device not 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.

Event Description

It was reported by the patient's wife the electrode covers "make him itchy".The patient's wife confirmed that it was the covers and not the electrodes themselves.The sales representative recommended that the patient should discontinue the use of the electrode covers and just use the electrodes.Zimvie customer service contacted the patient regarding the cover patches.The patient's wife stated that the cover patches are causing the skin to itch and become red.The patient's wife described the skin getting bumpy.The patient also had skin irritation from surgical tape at that time.The doctor prescribed a cream for the skin irritation.The patient¿s wife stated that she is using the same cream for the cover patches, but she does not have the name with her.The patient was sent replacement 72r electrodes.It was later reported on aug 19, 2022, that the patient's wife stated that her husband has a little irritation from the cover patches, his skin just gets a little red.She stated that the doctor has prescribed a salve for the irritation and the patient continues to treat with the unit.No additional patient consequences have been reported.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: ELECTRODES COVER PATCHES
• 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: 15396361
• MDR Text Key: 299667625
• Report Number: 0002242816-2022-00105
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067716
• Device Lot Number: 134018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male