FACEMASTER *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-28 for FACEMASTER * manufactured by *.

Event Text Entries

[502104] Rptr states that the referenced device needs conspicuous warnings to check the electrical stimulation setting before each use. Rptr states that she used the device at the wrong setting and suffered a severe migraine headache, vitral detachment with her eyes, developed floaters in her eyes & tinnitus.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4004185
• MDR Report Key: 757363
• Date Received: 2006-07-28
• Date of Report: 2006-05-05
• Date Added to Maude: 2006-09-07
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FACEMASTER
• Generic Name: FACIAL TONING DEVICE
• Product Code: NFO
• Date Received: 2006-07-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 745262
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-07-28