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); Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Rash (2033); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 04/29/2022

Event Type  Injury  

Event Description

It was reported by the sales rep that the patient had skin issues with the 72r electrodes.Patient stated her skin was red, itchy, raise, blistered with welts.Irritation was under the electrodes not the cover patches.Patient claims she changes the electrodes daily and rotates at that time.Patient cleans the skin with soap, water and alcohol pads.Patient claims she has sensitive skin and is allergic to penicillin and takes blood pressure medication.Patient contacted her surgeon and he suggested she use baskin wash for the irritated skin.The patient will rest the skin and then do a time test with alternative electrodes.

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: (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.

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 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 sales rep that the patient had skin issues with the 72r electrodes.Patient stated her skin was red, itchy, raise, blistered with welts.Irritation was under the electrodes not the cover patches.Patient claims she changes the electrodes daily and rotates at that time.Patient cleans the skin with soap, water and alcohol pads.Patient claims she has sensitive skin and is allergic to penicillin and takes blood pressure medication.Patient contacted her surgeon and he suggested she use baskin wash for the irritated skin.The patient will rest the skin and then do a time test with alternative electrodes.

• 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: 14444876
• MDR Text Key: 294685882
• Report Number: 0002242816-2022-00046
• 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: 03/20/2023

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: 133702
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female