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 that the patient is having an issue with the electrodes.The patient stated that she did not do a time test with the 63b electrodes.The patient stated that no one told her.The electrodes were changed and rotated every day.The skin was red and itchy with little bumps after the 2nd day.The patient called doctor but no one has gotten back to her.The patient was advised to wait until her skin is clear.Once the skin is clear the patient is going to do a time test.The patient spoke with someone from the doctor's office but there was no medical intervention.The patient stated , i didn't have sensitive skin until now." the patient stated that she does not have skin allergies but does take blood pressure medication.Customer service advised her to try using the electrodes for one hour for the first day.The sales rep advised her to use the electrodes for a half an hour per day.The patient mentioned developing skin tags from the rash but was not prescribed any medication or alternate treatment from the doctor's office.It was later reported that the patient alternated wearing one set of patches for one week and also tried changing them every day.The patient rotated locations.The patient cleans the area with soap, water and a wash cloth.The patient denies having sensitive skin, as well as no allergies or seasonal allergies.The patient claims there are no changes in her daily skin routine.She does take blood pressure medication.The patient reports seeing a dermatologist and was prescribed (b)(6).The patient will pause treating to clear skin and perform a time test.

Manufacturer Narrative

Zimmer biomet (b)(4).Date of event: the event occurred sometime in (b)(6) 2021.Medical product: depuy synthes 5x7mm.Medical product: depuy synthes (b)(6) with 17mm fixed and variable screws.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 that the patient is having an issue with the electrodes.The patient stated that she did not do a time test with the 63b electrodes.The patient stated that no one told her.The electrodes were changed and rotated every day.The skin was red and itchy with little bumps after the 2nd day.The patient called the doctor but no one has gotten back to her.The patient was advised to wait until her skin is clear.Once the skin is clear the patient is going to do a time test.The patient spoke with someone from the doctor's office but there was no medical intervention.The patient stated, ¿i didn't have sensitive skin until now." the patient stated that she does not have skin allergies but does take blood pressure medication.Customer service advised her to try using the electrodes for one hour or the first day.The sales rep advised her to use the electrodes for half an hour per day.The patient mentioned developing skin tags from the rash but was not prescribed any medication or alternate treatment from the doctor's office.It was later reported that the patient alternated wearing one set of patches for one week and also tried changing them every day.The patient rotated locations.The patient cleans the area with soap, water, and a washcloth.The patient denies having sensitive skin, as well as no allergies or seasonal allergies.The patient claims there are no changes in her daily skin routine.She does take blood pressure medication.The patient reports seeing a dermatologist and was prescribed betamethazone bp ointment.The patient will pause treatment to clear skin and perform a time test.

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 added.D3: manufacturer updated.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 to 4648 - insufficient information.H6: clinical code added to 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 conclusions code 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, 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: 12925586
• MDR Text Key: 283306558
• Report Number: 0002242816-2021-00216
• 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: 02/22/2023

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: 013201
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2021
• Initial Date FDA Received: 12/03/2021
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2020
• 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: Female