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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Rash (2033); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(6).Date of event: the event occurred sometime on (b)(6) 2023.Concomitant medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported by the patient stated that the 72r electrodes left marks and sores.The patient stated that the skin irritation started on the lumbar area and stopped wearing them that day.The patient wore the electrodes for 6 hours a day.The patient stated that the skin was red and itchy and that the sores appeared a few days.The patient stated that she only had one sore on the left side and the right side was red.The patient stated that the sore was bleeding and infected and was about 2 inches long and one inch wide.Prior to the sore, the skin was raw, and it looked like the outer couple layers of skin were gone.There were no blisters or welts, and the irritated skin was strictly under the electrodes.The patient changed and rotated the electrodes and cover patches every 3 to 5 days.The area was clean with soap and water.The patient only used alcohol for a few days on the skin.The patient does not have sensitive skin but is allergic to wellbutrin and gabapentin.The patient has seasonal allergies, does not use blood pressure medication and has not used any new product.The patient called the doctor and was connected to the sales representative.The patient applied cortisone cream twice daily and the sore healed in 8 days.After the sore healed, the patient restarted treatment.The patient changed and rotated the electrodes daily.The skin was red.The patient went to see her podiatrist when she had the sore on her back and was told not to use alcohol because it would dry out the skin.The podiatrist told the patient to only use the cortisone cream.The patient stated that the sales rep told her not to wear the cover patches and to skip a few days of treatment.The 63b electrodes have been sent to the patient.No further circumstances have been reported.

Event Description

It was reported by the patient stated that the 72r electrodes left marks and sores.The patient stated that the skin irritation started on the lumbar area and stopped wearing them that day.The patient wore the electrodes for 6 hours a day.The patient stated that the skin was red and itchy and that the sores appeared for a few days.The patient stated that she only had one sore on the left side and the right side was red.The patient stated that the sore was bleeding and infected and was about 2 inches long and one inch wide.Prior to the sore, the skin was raw, and it looked like the outer couple layers of skin were gone.There were no blisters or welts, and the irritated skin was strictly under the electrodes.The patient changed and rotated the electrodes and cover patches every 3 to 5 days.The area was clean with soap and water.The patient only used alcohol for a few days on the skin.The patient does not have sensitive skin but is allergic to wellbutrin and gabapentin.The patient has seasonal allergies, does not use blood pressure medication, and has not used any new product.The patient called the doctor and was connected to the sales representative.The patient applied cortisone cream twice daily and the sore healed in 8 days.After the sore healed, the patient restarted treatment.The patient changed and rotated the electrodes daily.The skin was red.The patient went to see her podiatrist when she had a sore on her back and was told not to use alcohol because it would dry out the skin.The podiatrist told the patient to only use the cortisone cream.The patient stated that the sales rep told her not to wear the cover patches and to skip a few days of treatment.The 63b electrodes have been sent to the patient.No further circumstances have been reported.

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 with unspecfied infection.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: 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: 16399313
• MDR Text Key: 309880706
• Report Number: 0002242816-2023-00010
• 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: 02/17/2023
• 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: 224506
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female