MAUDE Adverse Event Report: EBI, LLC. ELECTRODES COVER PATCHES

Catalog Number	106130-17
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported the patient also stated that the cover patches are causing skin irritation.The irritation is under the cover patches.The patient changes and rotates around 2 to 3 business days.The area is cleaned with soap and water.The patient has sensitive skin and is allergic to sulfa.The patient spoke to her doctor who told her to move the cover patches around and to use benadryl.I advised the patient not to use the cover patches.The patient has been using benadryl or hydrocortisone cream over the counter.The patient was sent replacement 72r electrodes.No further consequences have been reported at this time.
Additional Manufacturer Narrative
Corrections - b2: required intervention, b4: date of this report, b5: updated the product was not returned for evaluation, d3: manufacturer address and email address, g1: contact office and manufacturer site, g3, g6: report type, h6: impact code additional information - h4: device manufacture date, h6: method, h10: additional narrative, h11.This follow-up report is being submitted to relay additional and corrected information.The device was not returned to highridge medical for evaluation.The reported event was unable to be confirmed due to limited information received from the customer.The device history record could not be reviewed as the lot number of the cover patches is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Highridge medical will continue to monitor for trends.
Event or Problem Description
It was reported the patient also stated that the cover patches are causing skin irritation.The irritation is under the cover patches.The patient changes and rotates around 2 to 3 business days.The area is cleaned with soap and water.The patient has sensitive skin and is allergic to sulfa.The patient spoke to her doctor who told her to move the cover patches around and to use benadryl.I advised the patient not to use the cover patches.The patient has been using benadryl or hydrocortisone cream over the counter.The patient was sent replacement 72r electrodes.No further consequences have been reported at this time.The cover patches were not returned for evaluation.

• Brand Name: ELECTRODES COVER PATCHES
• Common Device Name: COVER PATCHES
• 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: brianne mcgill ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 19142632
• Report Number: 0002242816-2024-00053
• Device Sequence Number: 15314466
• Product Code: LOF
• UDI-Device Identifier: 00812301020195
• UDI-Public: 00812301020195
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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: Lay User/Patient
• Device Catalogue Number: 106130-17
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.; SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic