MAUDE Adverse Event Report: EBI, LLC 72R ELECTRODE; ELECTRODES

Catalog Number 106130-20

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Type  Injury  

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 Description

It was reported by the patient that he experienced discomfort while treating.He stated it began about one week ago.He stated he changed electrodes once per week, did not rotate position on the skin, and wears the electrodes under his brace.The pain was in his arm.He did not contact his doctor and did not take or apply anything to the area.The customer service representative advised the patient to take a break in treatment until he was pain free and then conduct a time test.The patient will contact his doctor and call back with any updates or issues.A replacement supply of 72r electrodes were shipped to the patient's home.No further consequences have been reported at this time.

• Brand Name: 72R ELECTRODE
• Type of Device: 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
• MDR Report Key: 18229173
• MDR Text Key: 329264276
• Report Number: 0002242816-2023-00129
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020331
• UDI-Public: 00812301020331
• 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
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106130-20
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic