MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; 72R ELECTRODES AND COVER PATCHES

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); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred at the end of june.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 patient that she had a skin irritation from the 72r electrodes since the end of june on cervical area.Skin is red and itchy with blisters.Irritation was strictly under the electrodes.The cover patches were used once and it caused a very bad rash.Patient has not worn the cover patches since.Electrodes are changed and rotated once a day or twice a day.The patient is allergic to latex, epinephrine, neosporin, morphine and demerol.Patient has skin dermatitis and eczema.The patient spoke to her dermatologist.The patient went to the dermatologist about the eczema.Doctor prescribed desoximetasone cream.25%.Sending 63b electrodes and usps pouch 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.

Event Description

It was reported by the patient that she had a skin irritation from the 72r electrodes since the end of june on cervical area.Skin is red and itchy with blisters.Irritation was strictly under the electrodes.The cover patches were used once and it caused a very bad rash.Patient has not worn the cover patches since.Electrodes are changed and rotated once a day or twice a day.The patient is allergic to latex, epinephrine, neosporin, morphine and demerol.Patient has skin dermatitis and eczema.The patient spoke to her dermatologist.The patient went to the dermatologist about the eczema.Doctor prescribed desoximetasone cream.25%.Sending 63b electrodes and usps pouch to the patient.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: 72R ELECTRODES AND 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: 12466455
• MDR Text Key: 271229027
• Report Number: 0002242816-2021-00166
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: 109101, 109535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 08/18/2021
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• 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