MAUDE Adverse Event Report: NSE PRODUCTS, INC. FACIAL SPA; NU SKIN FACIAL SPA

Model Number 90025509

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Malaise (2359); Convulsion/Seizure (4406); Unspecified Tissue Injury (4559)

Event Date 02/07/2021

Event Type  Injury  

Manufacturer Narrative

This device kit has been marketed and sold as a medical device since mid-2014 numbering over 200,000 units.This is our first occurrence that classifies as serious.In accordance with regulations regarding medical devices, a risk plan was created prior to fda approval aligning with fda guidance.Fda designates seizure as a potential risk of this cleared product type, and we determined that risk acceptable due to its extremely low probability of occurrence, a fact validated by multiple years of complaint data.Still, to mitigate against such risk, our label has always warned consumers the unlikely occurrence of this happening.In addition, as part of our risk plan, on a yearly basis we re-evaluate our risk analysis with all yearly known events.Regarding this occurrence, we received the customer's purchased facial spa and conductive gel and verified the facial spa is within specification.We are unable to substantiate the shipping and storage condition of the received conductive gel.We have reviewed the conductive gel at time of release and verified that it also met specification; no testing will be completed on the returned or retain sample of this particular batch.

Event Description

This spontaneous report was received from a consumer regarding a (b)(6)-year-old male patient on (b)(6) 2021.Reporter states that her boyfriend, the (b)(6)-year-old male patient, used the facial spa product (both nu skin facial spa and nu skin conductive gel), on (b)(6) 2021.On (b)(6) 2021 at approximately 0230 the patient had a seizure, unspecified type, and bit his tongue which resulted in bleeding.The patient did not have a previous history of seizures.After the seizure activity developed the reporter called emergency medical services (ems) and the patient was transported to the emergency department (ed).At the ed the patient had a computerized tomography scan (ct) and magnetic resonance imaging (mri).Both the ct and mri were normal.The treating practitioner was unsure what caused the seizure activity.The patient was monitored and observed in the ed for several hours but was not admitted to the hospital.He was prescribed unspecified anticonvulsant medication(s).At the time of the call on (b)(6) 2021 the reporter commented that the patient was improving but was still weak.An eeg is scheduled for the week of (b)(6) 2021.(b)(6) 2021: follow-up call made to the reporter.Reporter states that they are waiting for the eeg which is scheduled for tomorrow (b)(6) 2021.No further symptoms reported.(b)(6) 2021: follow-up call made to the reporter.Eeg was (b)(6) 2021, results are pending.No further symptoms reported.(b)(6) 2021: follow-up call made to the reporter.Eeg showed one single seizure with an unknown etiology.Patient will be following up with an unspecified specialist the week of (b)(6) 2021.No further symptoms reported.(b)(6) 2021: follow-up call with the reporter.The patient spoke with the doctor that morning and the doctor suspected the product could have caused the seizure based on the tests that were run and the consumer absence of prior seizure history.The patient will continue taking the prescribed seizure medication until his follow-up appointment on an unspecified date in (b)(6).His symptoms of weakness and overall malaise lasted for several weeks before subsiding.The patient was asymptomatic at the time of the contact.

• Brand Name: FACIAL SPA
• Type of Device: NU SKIN FACIAL SPA
• Manufacturer (Section D): NSE PRODUCTS, INC.; 75 w center street; provo UT 84601
• Manufacturer (Section G): NSE PRODUCTS, INC.; 75 w center street; provo UT 84601
• Manufacturer Contact: kenneth myers ; 75 w center street; provo, UT 84601 ; 8013452247
• MDR Report Key: 11516231
• MDR Text Key: 240697345
• Report Number: 3001236514-2021-00001
• Device Sequence Number: 1
• Product Code: NFO
• UDI-Device Identifier: 00860196000303
• UDI-Public: 00860196000303
• Combination Product (y/n): N
• PMA/PMN Number: K122711
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 90025509
• Device Lot Number: 0G5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NEXIUM; NU SKIN CONDUCTIVE GEL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 93