MAUDE Adverse Event Report: NUSKIN ENTERPRISES INC. AGELOC BOOST ACTIVATING SERUM DEVICE; STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES

Device Problem Material Discolored (1170)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 07/31/2022

Event Type  malfunction  

Event Description

I purchased the ageloc boost device and free 3 serum set on (b)(6) 2022.The 3 serum clearly stated expiry on august 2022.However, i noticed it change of colour (turn brown) on (b)(6) 2022 but i still continue used it until i felt there is breakout on my face.I report to the sale person via messenger on (b)(6) 2022 at 11.41pm, she checked with product specialist and stated to continue use the product as it is safe.

• Brand Name: AGELOC BOOST ACTIVATING SERUM DEVICE
• Type of Device: STIMULATOR, TRANSCUTANEOUS ELECTRICAL, AESTHETIC PURPOSES
• Manufacturer (Section D): NUSKIN ENTERPRISES INC.
• MDR Report Key: 15328122
• MDR Text Key: 299185231
• Report Number: MW5111815
• Device Sequence Number: 1
• Product Code: NFO
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female