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

Model Number N/A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

Pma/ 510k #: p850022/s017.The warnings in the package insert state this type of event can occur.The product was discarded by the patient and therefore 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 two of two for the same event.Report one of two is reported on mfr #0002242816-2016-00041.

Event Description

The patient reported that she received the spinalpak on (b)(6) 2016 to treat her lumbar spine.The patient states of the electrodes, 63b stuck the best, however it caused a rash that became swollen and infected.The patient advised she also used the cover patches with the electrodes.The patient advised she would change her electrodes every day because she would only wear them for twelve or more hours.The patient advised she moved the electrodes around when she changed them.The patient advised she went to her doctor who gave her a sample of topical antibiotic.

• Brand Name: ELECTRODE COVER PATCHES
• Type of Device: COVER PATCHES
• 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: 6166198
• MDR Text Key: 62122283
• Report Number: 0002242816-2016-00042
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• 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: 106130-17
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention