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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 08/16/2021

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 patient who stated that the 72r electrodes and cover patches caused a skin irritation.The skin irritation started about a month ago on the cervical area.The skin is red and itchy with welts and blisters.Now the patient has sores on his neck.The patient believes is from the 72r electrodes.The electrodes are changed every 2 to 3 days and are rotated daily.The area is clean with soap and water.No wipes.The patient does not have sensitive skin.The patient does not have any allergies.No new product.No blood pressure medication.The patient spoke to the doctor who advised him to stop using the stimulator again.The doctor did not prescribe anything for the skin irritation and was told not to put anything on the skin.The patient wanted to know if the electrodes were moved to a different position would it be ok to use the stimulator.The doctor told the patient to contact zb.72r electrodes lot # 109101 and cover patches lot # 109535.Sending 63b electrodes and usps pouch to the patient.The patient is going to wait until his skin is clear before starting the time test.

Manufacturer Narrative

This follow up report is being submitted to relay additional information.The device was not returned to zimmer biomet 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.Zimmer biomet will continue to monitor for trends.The following sections have been updated: b4: date of this report added 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 no h4: device manufacturer date added h6: component code updated to 4760 - patient electrode 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: h6: device code updated to 2993: adverse event without identified device or use problem.

Event Description

It was reported by the patient who stated that the 72r electrodes and cover patches caused a skin irritation.The skin irritation started about a month ago on the cervical area.The skin is red and itchy with welts and blisters.Now the patient has sores on his neck.The patient believes is from the 72r electrodes.The electrodes are changed every 2 to 3 days and are rotated daily.The area is clean with soap and water.No wipes.The patient does not have sensitive skin.The patient does not have any allergies.No new product.No blood pressure medication.The patient spoke to the doctor who advised him to stop using the stimulator again.The doctor did not prescribe anything for the skin irritation and was told not to put anything on the skin.The patient wanted to know if the electrodes were moved to a different position would it be ok to use the stimulator.The doctor told the patient to contact zb.72r electrodes lot # 109101 and cover patches lot # 109535.Sending 63b electrodes and usps pouch to the patient.The patient is going to wait until his skin is clear before starting the time test.

• Brand Name: SOFT-TOUCH ELECTRODES, 72R
• Type of Device: SOFT TOUCH ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 12466419
• MDR Text Key: 271227302
• Report Number: 0002242816-2021-00163
• 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: 11/23/2021

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: 106130-20
• Device Lot Number: 109101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2021
• Initial Date FDA Received: 09/14/2021
• Supplement Dates Manufacturer Received: 10/28/2021
• Supplement Dates FDA Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Male