MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; SPINAL PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R AND COVER PATCH)

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported by the that the patient is allergic reaction, irritation, and pain from 72r electrodes and cover patchess.The patient stated that her skin is itchy and breaking out.The patient stated that she is allergic to the adhesives.The patient wore the 72r electrodes and cover patches for about 7 hours and changed them once a day.The patient did not use any creams or ointments.The patient called the doctor, but never received a call back.The patient went to a pain management specialist and was told to take it off.The patient stated that she did feel some pain after the first few days and her husband noticed the scratches.The patient will try a time test with a 63b electrodes.No further consequesncs have been reported.

Manufacturer Narrative

The device was not returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with skin irritation, allergic reactions, and pain.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.Zimvie complaint (b)(4).Date of event: the event occurred sometime in january 2023.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R AND COVER PATCH)
• 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: 16456207
• MDR Text Key: 310406792
• Report Number: 0002242816-2023-00018
• Device Sequence Number: 1
• Product Code: LOF
• 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
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• 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: 221716/209112
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female