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

Model Number N/A

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Event Description

It was reported by the patient that his skin was about 99% healed before he tried the 63b electrodes.The patient wore the 63b electrodes for one hour for 3 days, then he started using them 24/7 while changing and rotating every day.The patient stated that he broke out after using the electrodes for an hour.The patient describes the skin as red and itchy, and it looks like poison ivy.The patient does have very sensitive skin.The ekg electrodes leave a mark for a month on his skin.He went to see his surgeon who advised told to try the best he could, but he has to continue using the electrodes.He does not have a lot of bone healing.The doctor did not prescribe anything.The patient was told that his skin has to be completely healed before he starts the time test.The patient is going to try the time test again.It was later reported that the patient is taking a break from treatment until his skin clears.He is not returning the product.The patient will continue using 63b electrodes once the skin has healed.His doctor did prescribe over the counter hydrocortisone.It was reported that no further information is available.

Manufacturer Narrative

(b)(4).Date of event: the event occurred sometime in (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 his skin was about 99% healed before he tried the 63b electrodes.The patient wore the 63b electrodes for one hour for 3 days, then he started using them 24/7 while changing and rotating every day.The patient stated that he broke out after using the electrodes for an hour.The patient describes the skin as red and itchy, and it looks like poison ivy.The patient does have very sensitive skin.The ekg electrodes leave a mark for a month on his skin.He went to see his surgeon who advised told to try the best he could, but he has to continue using the electrodes.He does not have a lot of bone healing.The doctor did not prescribe anything.The patient was told that his skin has to be completely healed before he starts the time test.The patient is going to try the time test again.It was later reported that the patient is taking a break from treatment until his skin clears.He is not returning the product.The patient will continue using 63b electrodes once the skin has healed.His doctor did prescribe over the counter hydrocortisone.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 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.H3: device evaluated by manufacturer updated to no.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 4114 - device not returned.H6: investigation code added to 4119 ¿ insufficient information available.H6: investigation findings code added to 3221: no findings available.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, 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: 12782778
• MDR Text Key: 281593924
• Report Number: 0002242816-2021-00193
• 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: 10/20/2022

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: 020001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 09/21/2022
• Supplement Dates FDA Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2020
• 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