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); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint# (b)(4).Date of event: (b)(6) 2022 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 that the patient has a skin irritation and itchy rash from the 72r electrodes.The stimulator also keeps beeping intermittently, and fresh electrodes were put on, so the rep believes it's the 20" lead wire.The patient's son reported that the patient wore the electrodes for 24 hours and changed them once a day.She did see the doctor, and he gave her otc cortizone.63b electrodes have been sent to the patient, and the patient will conduct a timed test and call back if there are any issues.A new 20" lead wire has also been sent to the patient.Old product will be returned.A return pouch has been sent to the patient.The patient does not take blood pressure medication.The patient has used otc cortisone cream and the skin has healed and she will be trying the 63b electrodes.

Event Description

It was reported by the sales rep that the patient has a skin irritation and itchy rash from the 72r electrodes.The stimulator also keeps beeping intermittently, and fresh electrodes were put on, so the rep believes it's the 20" lead wire.The patient's son reported that the patient wore the electrodes for 24 hours and changed them once a day.She did see the doctor, and he gave her otc cortizone.63b electrodes have been sent to the patient, and the patient will conduct a timed test and call back if there are any issues.A new 20" lead wire has also been sent to the patient.Old product will be returned.A return pouch has been sent to the patient.The patient does not take blood pressure medication.The patient has used otc cortisone cream and the skin has healed and she will be trying the 63b electrodes.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The device was not 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.The following sections have been updated: h3: device evaluated by manufacturer updated to no.H4: device manufacturer date added.H6: component code added to 451: electrode.H6: device code updated to 2682 - patient-device incompatibility.H6: investigation code added to 3331 - analysis of production records.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.The following sections have been corrected: h6: device code updated to 2993: adverse event without identified device or use problem.

• 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: 13431969
• MDR Text Key: 286350229
• Report Number: 0002242816-2022-00009
• 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: 04/26/2023

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: 106130-20
• Device Lot Number: 127249
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 04/11/2023
• Supplement Dates FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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