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

Model Number N/A

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

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the patient was experiencing pain and rash/irritation while using the device.Ana maria in cs called the patient regarding the skin irritation and pain all over her body.The patient stated she did not call the doctor.The patient took off the stimulator and the pain went away very gradually.The skin irritation started after 6 hours she put electrodes on the first time.The patient describes the skin as itchy and red.There are no welts or blisters.The electrodes were changed every 2 days and moved around slightly.The area is clean with soap and water.The patient has sensitive skin.The patient is allergic to adhesive, betadine, bandages, sterile strips, and tegaderm.She is also allergic to cilantro, sulfa, leryca, gabapentin, and statins.No seasonal allergies, wipes, or new products.The patient does not take blood pressure medication.The patient started at home physical therapy a week before starting the stimulator and has increased her daily activities.The pain was on the surface and below the skin.The pain level at night was a 9 and she spent 2 days in bed.The pain was an eight patient was walking.The patient was taking hydrocodone which was prescribed prior to the pain.The patient applied ice to the affected area.(b)(6) told the patient to stop using the electrodes until her skin is clear, once the skin is clear she can do the time test.63b electrodes were shipped to the patient.No additional patient consequences have been reported.

Manufacturer Narrative

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

It was reported that the patient was experiencing pain and rash/irritation while using the device.Ana maria in cs called the patient regarding the skin irritation and pain all over her body.The patient stated she did not call the doctor.The patient took off the stimulator and the pain went away very gradually.The skin irritation started after 6 hours she put electrodes on the first time.The patient describes the skin as itchy and red.There are no welts or blisters.The electrodes were changed every 2 days and moved around slightly.The area is clean with soap and water.The patient has sensitive skin.The patient is allergic to adhesive, betadine, bandages, sterile strips, and tegaderm.She is also allergic to cilantro, sulfa, leryca, gabapentin, and statins.No seasonal allergies, wipes, or new products.The patient does not take blood pressure medication.The patient started at home physical therapy a week before starting the stimulator and has increased her daily activities.The pain was on the surface and below the skin.The pain level at night was a 9 and she spent 2 days in bed.The pain was an eight patient was walking.The patient was taking hydrocodone which was prescribed prior to the pain.The patient applied ice to the affected area.Ana maria told the patient to stop using the electrodes until her skin is clear, once the skin is clear she can do the time test.63b electrodes were shipped to the patient.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was returned to zimvie for investigation.The reported event was not verifiable after the investigation associated with pain and 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.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R)
• 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: 15629186
• MDR Text Key: 301980701
• Report Number: 0002242816-2022-00123
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020201
• UDI-Public: 00812301020201
• 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: 03/21/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067716
• Device Lot Number: 209102
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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: Female