MAUDE Adverse Event Report: EBI, LLC. SPINALPAK 20" LEAD WIRES

Model Number N/A

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

Patient Problems Itching Sensation (1943); Skin Irritation (2076); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Pma#: p850022/s017.The product was not returned for an evaluation by the patient.Because the lot number is unknown, the device history records could not be pulled and reviewed.The patient advised she has mono and was taking antibiotics before the bumps appeared.The patient advised the emergency room staff believes the patient was suffering from an allergic reaction to the antibiotic medication she was taking for mono.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 that she received the spinalpak three weeks prior to (b)(6) 2016.The patient reported experiencing red bumps where the lead wire runs up her neck as well as elsewhere on her body.The patient advised she has mono and was taking antibiotics before the bumps appeared.The patient advised she went to the emergency room on (b)(6) 2016 where she was given benadryl.The patient stated the medication allowed her to sleep.But, the next day her symptoms had worsened and she had to go back to the emergency room where she was given steroids and hydroxyzine.The patient advised the emergency room staff believes the patient was suffering from an allergic reaction to the antibiotic medication she was taking for mono.

• Brand Name: SPINALPAK 20" LEAD WIRES
• Type of Device: LEAD WIRES
• 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: 6120819
• MDR Text Key: 60661643
• Report Number: 0002242816-2016-00038
• 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: 11/01/2016

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: 1067724-2
• 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: 11/01/2016
• 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