MAUDE Adverse Event Report: EBI, LLC. SOFT-TOUCH ELECTRODES, 63B

Model Number N/A

Device Problems Component Incompatible (1108); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Skin Burning Sensation (4540); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.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 that he had irritation with the 63b electrodes.The patient claims his skin was burned and red after 5 to 10 seconds on the skin.The spinalpak was not connected to the electrodes at the time.The patient rated her pain as a 10 on a scale of 1 to 10, which is considered severe and the burning sensation was shocking and painful.The patient removed the electrodes immediately and cleansed the skin with cold water, and eventually soap and water.The patient reports welts on the skin.There are no blisters and no itchiness.The irritation was directly under the electrodes and did not have an opportunity to rotate.The patient will not rotate in the future.The patient has sensitive skin and claims when he was treated in 2019, he had the same issues.He reports an allergy to benadryl.He has seasonal allergies and also asthma.The patient does not take blood pressure medication and has not used any creams.He has not spoken with a medical representative.It was later reported on july 13, 2022, that the patient stated he spoke to his nurse who told him to stop using the bone stimulator.It was reported that no further information is available.

Event Description

It was reported by the patient that he had irritation with the 63b electrodes.The patient claims his skin was burned and red after 5 to 10 seconds on the skin.The spinalpak was not connected to the electrodes at the time.The patient rated her pain as a 10 on a scale of 1 to 10, which is considered severe and the burning sensation was shocking and painful.The patient removed the electrodes immediately and cleansed the skin with cold water, and eventually soap and water.The patient reports welts on the skin.There are no blisters and no itchiness.The irritation was directly under the electrodes and did not have an opportunity to rotate.The patient will not rotate in the future.The patient has sensitive skin and claims when he was treated in 2019, he had the same issues.He reports an allergy to benadryl.He has seasonal allergies and also asthma.The patient does not take blood pressure medication and has not used any creams.He has not spoken with a medical representative.It was later reported on (b)(6) 2022, that the patient stated he spoke to his nurse who told him to stop using the bone stimulator.It was reported that no further information is available.

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 pain, skin irritation, and burning sensation.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, 63B
• 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: 15164278
• MDR Text Key: 297241265
• Report Number: 0002242816-2022-00077
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• 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

• 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: 106130-22
• Device Lot Number: 025401
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• 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
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Sex: Male