THE SALT FACIAL

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-05 for THE SALT FACIAL manufactured by Med-aesthestic Solutions.

Event Text Entries

[138078457] The representative of (b)(6), who trains physicians to use the? Salt facial device? Performed a? Salt facial? Using the device manufactured by med-aesthetics solutions on me on (b)(6) 2018. During the procedure, i was anesthetized and given nitrous oxide. During the procedure ms. (b)(6) stopped midway and when i looked in the mirror i saw my face was scarred with dark stripes and sensitive to touch. Ms. (b)(6) stated that the machine was not? Calibrated? And that the scars were a result of that and then stated that the problem was one that the machine was known for and that a new generation machine was being developed. After the procedure, my face was damaged on both sides with multiple stripes and discoloration. I was advised to moisturize with vaseline and that it would clear up. She then prescribed several topical treatments and sent them to me via mail. I tried the products as instructed with minimal results. Three months later, i saw a dermatologist and was diagnosed with post inflammatory hyperpigmentation and advised to have multiple expensive procedures that would take a course of four months with no guarantee of results. I have been contacted by the company president mr. (b)(4) who stated that the machine was not the problem but the operator. I don? T know who to believe but something is wrong. I am a physician and perform aesthetic procedures daily. There is no explanation that has been given as to how my face was so severely damaged. Mr. (b)(4) states he repossessed the machine and had it tested and that there is no problem with it. Ms. (b)(6) claims that she is in the process of improving the device as the problem is one known by her caused by the machine. Regardless, i would hate to see this happen to anyone else. Please let me know if this device is fda approved and if there are other similar complaints. Dr. (b)(6), med-aesthetics solutions.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084679
MDR Report Key8394239
Date Received2019-03-05
Date of Report2019-03-01
Date of Event2018-12-08
Date Added to Maude2019-03-06
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameTHE SALT FACIAL
Generic NameBRUSH, DERMABRASION POWERED
Product CodeGFE
Date Received2019-03-05
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerMED-AESTHESTIC SOLUTIONS


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-05

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