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)

Patient Problems Burn(s) (1757); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported that the 72r electrodes irritated and burnt the patient's skin.The patient describes the electrodes as having "exploded" on his skin.He states he also had blisters.The patient changed them every other day and rotated the position on his skin.He states that he wears them on his neck.The patient does not have sensitive skin, and he did not seek medical treatment, but he applied burn cream and hydrocortisone cream to the area.Customer service advised him to take a break in treatment until his skin is completely healed, then conduct a time test with 63b electrodes.They discussed changing the position of electrodes each day and advised him to call back with any issues during the time test.The patient was sent replacement 63b electrodes.It was later reported on (b)(6) 2022, the patient has two scars on the back of his neck from the "burns" from the 72r electrodes from march 2022.Shortly after the conversation in march, the patient had an appointment with his doctor, and he suggested an otc cortisone cream, which helped his irritation/burns.The patient stated he was pleased with the treatment, with the exception of the burns.It was reported that no further information is available.

Manufacturer Narrative

The device was not returned to zimmer biomet for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Zimvie complaint (b)(4).Date of event: the event occurred sometime in march 2022.Medical product: unknown.Therapy date: unknown.

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 and skin burn.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 added.D3: manufacturer updated.D4: lot number added.G1: contact office updated.G3: date received by manufacturer added.G6: type of report.H2: follow up type.H3: device evaluated by manufacturer updated to yes h4: device manufacturer date added h6: component codes added 451-electrodes h6: impact code added 4648-insufficient information h6: clinical code added 4545 - skin inflammation/ irritation h6: clinical code added 1757 - burn(s) h6: clinical code added 4537 - blister 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.

Event Description

It was reported that the 72r electrodes irritated and burnt the patient's skin.The patient describes the electrodes as having "exploded" on his skin.He states he also had blisters.The patient changed them every other day and rotated the position on his skin.He states that he wears them on his neck.The patient does not have sensitive skin, and he did not seek medical treatment, but he applied burn cream and hydrocortisone cream to the area.Customer service advised him to take a break in treatment until his skin is completely healed, then conduct a time test with 63b electrodes.They discussed changing the position of electrodes each day and advised him to call back with any issues during the time test.The patient was sent replacement 63b electrodes.It was later reported on (b)(6) 2022, the patient has two scars on the back of his neck from the "burns" from the 72r electrodes from (b)(6) 2022.Shortly after the conversation in (b)(6), the patient had an appointment with his doctor, and he suggested an otc cortisone cream, which helped his irritation/burns.The patient stated he was pleased with the treatment, with the exception of the burns.It was reported that no further information is available.

• 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: 15117911
• MDR Text Key: 296758242
• Report Number: 0002242816-2022-00076
• 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: 04/03/2023

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: 118101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/04/2023
• 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: Male