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

Catalog Number 106130-22

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

Patient Problems Itching Sensation (1943); Blister (4537); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).B3: date of event: the event occurred sometime in (b)(6) 2023.D11: medical product: unknown.D11: 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 the the 63b electrodes irritated her skin.The patient did not do the time test when she switched the electrodes.Patient treats 12 hours and rests the skin for 12 hours.The patient stated she washes her skin with warm water and uses hydrocortisone cream in between.The patient never spoke with her doctor about the irritation because she has always had sensitive skin.The patient's skin was red, itchy and had blisters.The patient would like to go back to 72r electrodes as the irritation was not as bad as with those.The patient will perform the timed test for 2 days at each stage and report back if there are any issues.The 72r electrodes were shipped to the patient.It was later reported by the patient that every single electrode that she has used has caused skin irritation.The patient spoke to her doctor and was told to discontinue using the electrodes.The doctor did not prescribe anything.The patient was using hydrocortisone over the counter.The only thing that helped the patient was not using the electrodes.The patient used the unit for as long as possible.The patient had red and itchiness, a rash, significant contact dermatitis, and open wounds from scratching.The patient did not take any pictures of the skin irritation.The patient will send back one pack of each electrode she has used.

Manufacturer Narrative

Additional information in h6: patient code, device code, component, method, results, and conclusions.The device was returned to zimvie and the investigation is complete.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 review of 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.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported by the patient that the 63b electrodes irritated her skin.The patient did not do the time test when she switched the electrodes.Patient treats 12 hours and rests the skin for 12 hours.The patient stated she washes her skin with warm water and uses hydrocortisone cream in between.The patient never spoke with her doctor about the irritation because she has always had sensitive skin.The patient's skin was red, itchy and had blisters.The patient would like to go back to 72r electrodes as the irritation was not as bad as with those.The patient will perform the timed test for 2 days at each stage and report back if there are any issues.The 72r electrodes were shipped to the patient.It was later reported by the patient that every single electrode that she has used has caused skin irritation.The patient spoke to her doctor and was told to discontinue using the electrodes.The doctor did not prescribe anything.The patient was using hydrocortisone over the counter.The only thing that helped the patient was not using the electrodes.The patient used the unit for as long as possible.The patient had red and itchiness, a rash, significant contact dermatitis, and open wounds from scratching.The patient did not take any pictures of the skin irritation.The patient will send back one pack of each electrode she has used.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Type of Device: 63B ELECTRODES
• Manufacturer (Section D): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC; 1 gatehall dr; suite 303; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 17375403
• MDR Text Key: 319549579
• Report Number: 0002242816-2023-00082
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (y/n): N
• Reporter Country Code: US
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106130-22
• Device Lot Number: 132301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic