MAUDE Adverse Event Report: EBI, LLC. SPINALPAK ASSEMBLY; BONE GROWTH STIMULATOR

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.The patient has stated that they have very sensitive skin, which could be a contribution factor to the event.The dhr was reviewed and the product passed all stages of testing and no discrepancies were noted.If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.

Event Description

The patient states that she has an irritation from the electrodes and that she wears both the electrodes and cover patches.The patient also claims that she changes the electrodes every 3 to 4 days but does not move the location of the electrodes.She took the electrodes off for a week to let the area heal.Once the electrodes were put back onto the skin at 7:00am redness had returned by 3:00pm.The patient stated she went to her dermatologist on (b)(6) 2015.She was prescribed mometasone furoate cream and topicort spray.

• Brand Name: SPINALPAK ASSEMBLY
• Type of Device: BONE GROWTH STIMULATOR
• 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: 5357089
• MDR Text Key: 35532982
• Report Number: 0002242816-2016-00002
• 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: 01/08/2016

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 Model Number: N/A
• Device Catalogue Number: 1067716
• Device Lot Number: N/A
• Other Device ID Number: (01)00888480587903(21)L13393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2015
• Initial Date FDA Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention