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

Catalog Number 106130-20

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

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.

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.No additional patient consequences have been reported.72r electrodes were not returned for further evaluation.

Manufacturer Narrative

Corrections in b4: date of the report, b5: event description, d3: manufacturer g1: contact office, g6: type of report, h2, h8 and h3.Additional information in h4: device manufacture date, h6: component, investigation type, findings, and conclusions and h10: additional narrative.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.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.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 trend.

• 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: drashti patel ; 1 gatehall dr; suite 303; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 18229173
• MDR Text Key: 329264276
• Report Number: 0002242816-2023-00129
• Device Sequence Number: 1
• Product Code: LOF
• 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: 05/29/2024

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106130-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• 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.; SEE H10 NARRATIVE.
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic