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

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); Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the patient had an allergic reaction using the 72r electrodes and cover patches.The patient stated that she has had a skin reaction since the second week she started treating.The skin is red and itchy, and the patient has blisters and welts.The patient does not know if it is under the electrodes and/or the cover patches.The patient changes her electrodes and cover patches every day, but she did not move them around.She spoke to the doctor over the phone, who told her to stop using the electrodes and cover patches for 2 weeks and to apply (b)(6).The patient went to her doctor's appointment, and she was told to use the unit while she is awake and to change and rotate the electrodes daily.The patient is still having skin irritation.The patient had to use the cover patches because the electrodes were not staying on her skin.The area is clean with (b)(6), and no wipes have been used.The patient does have sensitive skin, she is allergic to (b)(6), and she does have (b)(6).The patient used the electrodes about 10 years ago and had the same skin reaction.No new product has been used.The patient takes (b)(6) medication.The doctor only told her to use (b)(6).

Manufacturer Narrative

Zimmer biomet (b)(4).Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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 allergic reaction 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.

Event Description

It was reported that the patient had an allergic reaction using the 72r electrodes and cover patches.The patient stated that she has had a skin reaction since the second week she started treating.The skin is red and itchy, and the patient has blisters and welts.The patient does not know if it is under the electrodes and/or the cover patches.The patient changes her electrodes and cover patches every day, but she did not move them around.She spoke to the doctor over the phone, who told her to stop using the electrodes and cover patches for 2 weeks and to apply caladryl lotion.The patient went to her doctor's appointment, and she was told to use the unit while she is awake and to change and rotate the electrodes daily.The patient is still having skin irritation.The patient had to use the cover patches because the electrodes were not staying on her skin.The area is clean with alcohol, and no wipes have been used.The patient does have sensitive skin, she is allergic to latex, and she does have seasonal allergies.The patient used the electrodes about 10 years ago and had the same skin reaction.No new product has been used.The patient takes high blood pressure medication.The doctor only told her to use caladryl lotion.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: SPINAL PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R/ 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: 13286672
• MDR Text Key: 284878986
• Report Number: 0002242816-2022-00003
• 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,Followup
• Report Date: 03/10/2023

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: 112401/115141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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: Female