MAUDE Adverse Event Report: EBI, LLC. SPINALPAK SOFT-TOUCH ELECTRODES, 72R

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Skin Irritation (2076); Wheal(s) (2241)

Event Type  Injury  

Manufacturer Narrative

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.The patient reported going to the urgent care the weekend prior to (b)(6) 2016 where she was told she was having an allergic reaction to the 72r electrodes.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

The patient reported receiving the spinalpak on (b)(6) 2016.Soon after she experienced itching and painful blisters on both sides of the spinal column under the electrodes on her lower back.The patient reported going to the urgent care the weekend prior to (b)(6) 2016 where she was told she was having an allergic reaction to the 72r electrodes.The patient advised she was also using cover patches.The patient advised she changed her electrodes every three days or more when the cover patches no longer held the electrodes in place.The patient advised she'd move the electrodes a little bit.The patient advised she received triamcinolone, prednisone, and hydroxyzine from the urgent care center.The patient advised she was told to discontinue use by her surgeon.

• Brand Name: SPINALPAK SOFT-TOUCH ELECTRODES, 72R
• 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: 6120903
• MDR Text Key: 60685416
• Report Number: 0002242816-2016-00039
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• 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: 106130-20
• 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: 11/10/2016
• 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