MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B

Model Number N/A

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

Patient Problems Abrasion (1689); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet 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 zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient is having a skin irritation with the 63b electrodes.The 63b electrodes are causing welts and itchiness on the lumbar area.The patient does not use the cover patches.The electrodes are changed and rotated every day.The area is cleaned with soap and water.The patient uses hydrocortisone cream on the area.The patient does not have sensitive skin or allergies, and she has not used any wipes.The patient takes blood pressure medication.She did not speak to the doctor.The patient was sent replacement 72r electrodes.It was alter reported that the patient has received the 72r electrodes a and used them last night.The patient stated that she is having no issues with the new electrodes.The patient stated that she did contact the doctor regarding the skin irritation with the 63b electrodes and the doctor told her to use cortisone cream.The patient uses an over the counter cortisone cream and a benadryl cream.

Manufacturer Narrative

Zimmer biomet 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 zimmer biomet for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that the patient is having a skin irritation with the 63b electrodes.The 63b electrodes are causing welts and itchiness on the lumbar area.The patient does not use the cover patches.The electrodes are changed and rotated every day.The area is cleaned with soap and water.The patient uses hydrocortisone cream on the area.The patient does not have sensitive skin or allergies, and she has not used any wipes.The patient takes blood pressure medication.She did not speak to the doctor.The patient was sent replacement 72r electrodes.It was alter reported that the patient has received the 72r electrodes a and used them last night.The patient stated that she is having no issues with the new electrodes.The patient stated that she did contact the doctor regarding the skin irritation with the 63b electrodes and the doctor told her to use cortisone cream.The patient uses an over the counter cortisone cream and a benadryl cream.

Event Description

It was reported that the patient is having skin irritation with the 63b electrodes.The 63b electrodes are causing welts and itchiness in the lumbar area.The patient does not use the cover patches.The electrodes are changed and rotated every day.The area is cleaned with soap and water.The patient uses hydrocortisone cream on the area.The patient does not have sensitive skin or allergies, and she has not used any wipes.The patient takes blood pressure medication.She did not speak to the doctor.The patient was sent replacement 72r electrodes.It was later reported that the patient has received the 72r electrodes a and used them last night.The patient stated that she is having no issues with the new electrodes.The patient stated that she did contact the doctor regarding the skin irritation with the 63b electrodes and the doctor told her to use cortisone cream.The patient uses an over-the-counter cortisone cream and a benadryl cream.It was reported that no further information is available.

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.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Type of Device: ELECTRODES
• 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: 13609047
• MDR Text Key: 286231623
• Report Number: 0002242816-2022-00018
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850022/S017
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• 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: 106130-22
• Device Lot Number: 022901
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female