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 Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 05/14/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: (b)(6) 2021.Medical product: unknown.Therapy date: unknown.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 has an allergic reaction on her back from the 72r electrodes and cover patches.The patient went to see her doctor on (b)(6) 2021 who told the patient to take off the electrodes and cover patches until it clears.The doctor told the patient to use hydrocortisone cream over the counter.The skin was red and itchy with blisters and welts.The skin irritation started round like the electrodes but now they are blotchy.The electrodes and cover patches were changed and rotated them every 3 days.The area is clean with soap and water.No wipes.No new product.No blood pressure medication.I told the patient to wait until her skin is clear before doing the time test with the 63b electrodes.I also told the patient not to wear the cover patches.The patient has a pre-paid envelope from a previous complaint that she is using to return the electrodes and cover patches.New 63b electrodes were shipped to the patient.

Event Description

It was reported by the patient that she has an allergic reaction on her back from the 72r electrodes and cover patches.The patient went to see her doctor on (b)(6) 2021 who told the patient to take off the electrodes and cover patches until it clears.The doctor told the patient to use hydrocortisone cream over the counter.The skin was red and itchy with blisters and welts.The skin irritation started round like the electrodes but now they are blotchy.The electrodes and cover patches were changed and rotated them every 3 days.The area is clean with soap and water.No wipes.No new product.No blood pressure medication.I told the patient to wait until her skin is clear before doing the time test with the 63b electrodes.I also told the patient not to wear the cover patches.The patient has a pre-paid envelope from a previous complaint that she is using to return the electrodes and cover patches.New 63b electrodes were shipped 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.The following sections have been updated: b4 date of this report updated d3 manufacturer updated g1-2 contact office updated g3: date received by manufacturer added g6: type of report updated h2: follow up type updated h3: device evaluated by manufacturer updated to yes h4 device manufacturer date added h6: component codes added 451 - electrode h6: impact code added 4648-insufficient information h6: clinical code added 1943-itching sensation h6: clinical code added 1907 - hypersensitivity/allergic reaction h6: clinical code added 4537 - blister h6: clinical code added 4545 - skin inflammation/ irritation 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 h6: investigation conclusion added to 4315- cause not established h10: additional narratives/data 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: 12167502
• MDR Text Key: 261521299
• Report Number: 0002242816-2021-00125
• 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: 02/07/2023

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: 100101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/14/2021
• Supplement Dates Manufacturer Received: 06/21/2021
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• 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