MAUDE Adverse Event Report: EBI, LLC. ELECTRODES, LT-4500

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

Pmk/510 # p80022/s017.The warnings in the package insert state this type of even can occur.The product was discarded by the patient; therefore it will not be returned for an evaluation.Because the lot number is unknown, the device history records could not be pulled and 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.This is report 1 of 3 for the same event.Reports 2 and 3 are reported on mfr #0002242816-2016-00028 and 0002242816-2016-00029.

Event Description

The sales representative reported that the patient experienced a burn from using lt 4500 electrodes and 63b electrodes with the spinalpak.The patient went to his doctor for his symptoms.His doctor prescribed him a cream.The patient advised he had to miss some work days as a result of the burns.

• Brand Name: ELECTRODES, LT-4500
• Type of Device: ELECTRODES
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 5974091
• MDR Text Key: 55560177
• Report Number: 0002242816-2016-00027
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP80022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 106130-12
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention