MAUDE Adverse Event Report: EBI, LLC. SPINAL PAK 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 Pressure Sores (2326); Skin Inflammation/ Irritation (4545)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021.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 sales rep, that the 72r electrodes are causing skin irritation to patient.Irritation started last month, skin is itching with sores.Electrodes and cover patches left a residual on the skin.The irritation started last month.The skin is itching with sores.The electrodes and the cover patches left a residual on the skin and the patient scratch.The patient changed and rotated the electrodes and cover patches every 2 days.The area is clean with soap and water.No wipes.The patient stated that it could be from the new soap (teals).It was a new soap.The patient has sensitive skin.No allergies.The patient takes blood pressure medication.The patient called the doctor's office he was told to change the patches to a different area and to clean it before applying the cover patches.72r electrodes lot # 020701 and cover patches lot # 023049.I told the patient to remove the electrodes and wait until his skin is clear before starting the time test.The patient's unit is going to time out in a few days.The sales rep is working on getting a new prescription and clinicals for a replacement unit.Sending 63b electrodes and usps pouch to the patient.Spoke to the patient this morning regarding the skin irritation.I am sending 63b electrodes and no cover patches as he is not sure which caused the skin irritation.New 63b electrodes were shipped to the patient.

Event Description

It was reported by the sales rep, that the 72r electrodes are causing skin irritation to patient.Irritation started last month, skin is itching with sores.Electrodes and cover patches left a residual on the skin.The irritation started last month.The skin is itching with sores.The electrodes and the cover patches left a residual on the skin and the patient scratch.The patient changed and rotated the electrodes and cover patches every 2 days.The area is clean with soap and water.No wipes.The patient stated that it could be from the new soap (teals).It was a new soap.The patient has sensitive skin.No allergies.The patient takes blood pressure medication.The patient called the doctor's office he was told to change the patches to a different area and to clean it before applying the cover patches.72r electrodes lot # 020701 and cover patches lot # 023049.I told the patient to remove the electrodes and wait until his skin is clear before starting the time test.The patient's unit is going to time out in a few days.The sales rep is working on getting a new prescription and clinicals for a replacement unit.Sending 63b electrodes and usps pouch to the patient.Spoke to the patient this morning regarding the skin irritation.I am sending 63b electrodes and no cover patches as he is not sure which caused the skin irritation.New 63b electrodes were shipped to the patient.

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.The following sections have been updated: b4: date of this report added.D3 manufacturer updated.G1-2: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to yes.H4: device manufacturer date added.H6: component codes added to 451: electrodes.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation findings code added to 3221: no findings available.H10: additional narratives/data.The following sections have been corrected: d4 additional device information.H6: device code updated to 2993: adverse event without identified device or use problem.D2: type of device.

• Brand Name: SPINAL PAK 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: 12466453
• MDR Text Key: 271228517
• Report Number: 0002242816-2021-00167
• 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: 09/30/2022

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: 020701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/20/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 08/20/2021
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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: Male