MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 72R; SOFT TOUCH ELECTRODES

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); Skin Inflammation/ Irritation (4545)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (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.Who stated that the patient's 72r electrodes caused irritation on left arm.The irritation started about a week ago.The skin is red and itchy with little bumps but no blisters.The electrodes were changed daily or sometimes twice a day.The cover patches irritated her skin as well.The patient discontinued using the cover patches.The 72r electrodes were originally being used on the same spot, and once the irritation started the patient moved the electrodes.The area is cleaned with soap and water, no wipes.The patient does not have sensitive skin, or allergies.No new product.The patient does not take blood pressure medication.The patient went to see the doctor last week and she was told to stop using the electrodes.The doctor told the patient to use aquaphor however, it did not help.The patient is using (b)(6) oil.The doctor did tell there was bone growth.The patient was advised to wait until her skin is completely clear.Once the skin is clear the patient can start the time test with the different type of electrodes, 63b.

Event Description

It was reported by the sales rep.Who stated that the patient's 72r electrodes caused irritation on left arm.The irritation started about a week ago.The skin is red and itchy with little bumps but no blisters.The electrodes were changed daily or sometimes twice a day.The cover patches irritated her skin as well.The patient discontinued using the cover patches.The 72r electrodes were originally being used on the same spot, and once the irritation started the patient moved the electrodes.The area is cleaned with soap and water, no wipes.The patient does not have sensitive skin, or allergies.No new product.The patient does not take blood pressure medication.The patient went to see the doctor last week and she was told to stop using the electrodes.The doctor told the patient to use aquaphor however, it did not help.The patient is using vitamin e oil.The doctor did tell there was bone growth.The patient was advised to wait until her skin is completely clear.Once the skin is clear the patient can start the time test with the different type of electrodes, 63b.

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, 72R
• Type of Device: SOFT TOUCH 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: 13020216
• MDR Text Key: 282811637
• Report Number: 0002242816-2021-00227
• 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/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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• 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: 106130-20
• Device Lot Number: 118101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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