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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Rash (2033); Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device not 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.Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.
Event or Problem Description
It was reported that the 63b electrode glue is making the patient's skin break out.She was advised to take a break until her skin clears up.The patient stated she wore 63b electrode 24/7 then cut down to 12 hours.The nurse recommended cortisone cream.The patient did not speak to her doctor.She did not rotate the covers did rotate.The patient has an allergy to latex and has sensitive skin.The patient will wait for her skin to heal then try a couple of hours for a week and see if that works.She is also going to try and remove the glue off of the electrodes and put the covers over them to keep them in place and see if that works.No additional patient consequences have been reported.
Event or Problem Description
It was reported that the 63b electrode glue is making the patient's skin break out.She was advised to take a break until her skin clears up.The patient stated she wore 63b electrode 24/7 then cut down to 12 hours.The nurse recommended cortisone cream.The patient did not speak to her doctor.She did not rotate the covers did rotate.The patient has an allergy to latex and has sensitive skin.The patient will wait for her skin to heal then try a couple of hours for a week and see if that works.She is also going to try and remove the glue off of the electrodes and put the covers over them to keep them in place and see if that works.No additional patient consequences have been reported.The 63b electrode was not returned for evaluation.
Additional Manufacturer Narrative
It was reported that the 63b electrode glue is making the patient's skin break out.She was advised to take a break until her skin clears up.The patient stated she wore 63b electrode 24/7 then cut down to 12 hours.The nurse recommended cortisone cream.The patient did not speak to her doctor.She did not rotate the covers did rotate.The patient has an allergy to latex and has sensitive skin.The patient will wait for her skin to heal then try a couple of hours for a week and see if that works.She is also going to try and remove the glue off of the electrodes and put the covers over them to keep them in place and see if that works.No additional patient consequences have been reported.The 63b electrode was not returned for evaluation.
Event or Problem Description
It was reported that the 63b electrode glue is making the patient's skin break out.She was advised to take a break until her skin clears up.The patient stated she wore 63b electrode 24/7 then cut down to 12 hours.The nurse recommended cortisone cream.The patient did not speak to her doctor.She did not rotate the covers did rotate.The patient has an allergy to latex and has sensitive skin.The patient will wait for her skin to heal then try a couple of hours for a week and see if that works.She is also going to try and remove the glue off of the electrodes and put the covers over them to keep them in place and see if that works.No additional patient consequences have been reported.The 63b electrode was not returned for evaluation.
Additional Manufacturer Narrative
It was reported that the 63b electrode glue is making the patient's skin break out.She was advised to take a break until her skin clears up.The patient stated she wore 63b electrode 24/7 then cut down to 12 hours.The nurse recommended cortisone cream.The patient did not speak to her doctor.She did not rotate the covers did rotate.The patient has an allergy to latex and has sensitive skin.The patient will wait for her skin to heal then try a couple of hours for a week and see if that works.She is also going to try and remove the glue off of the electrodes and put the covers over them to keep them in place and see if that works.No additional patient consequences have been reported.The 63b electrode was not returned for evaluation.

• Brand Name: SOFT-TOUCH ELECTRODES, 63B
• Common Device Name: 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: 15628859
• Report Number: 0002242816-2022-00121
• Device Sequence Number: 2748746
• Product Code: LOF
• UDI-Device Identifier: 00880304820852
• UDI-Public: 00880304820852
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P850022/S017
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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
• Operator of Device: Other
• Device Model Number: N/A
• Device Catalogue Number: 106130-22
• Device Lot Number: 032301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 06/07/2024; 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic