MAUDE MDR 7910517

MDR report key
7910517
Report number
MW5080133
Event key
0
Event type
3
Date of event
2018-02-27
Date received
2018-09-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTHERAPYFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULARMERZ NORTH AMERICA, INC.OHVI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-250

Event Narratives#

D

Patient 1

I RECEIVED ULTHERAPY ON MY FACE AND NECK. WAS TOLD IT WAS NON-INVASIVE HEATED ULTRASOUND TO LIFT TIGHTEN AND TONE. ITS MAIN THING IS TO STIMULATE COLLAGEN. I WAS TOLD ONLY SIDE EFFECTS COULD BE MILD DISCOMFORT AND POSSIBLY NOT A NOTICEABLE DIFFERENCE. RESULTS ARE SUPPOSED TO SHOW 3-6 MONTH. AT 2 MONTHS I NOTICED CHANGES, BY 4 MONTHS MY FACE HAD BEEN DEPLETED OF FAT, AND I?M LEFT WITH DEEP HOLLOWS AND NERVE DAMAGE. I WAS TOLD IT DOESN?T TOUCH YOUR FAT LAYER. I?VE SINCE DISCOVERED IT CAN, AND HEATED ULTRASOUND IS ACTUALLY USED TO DEPLETE FAT AND DESTROY CELLS IN OTHER SITUATIONS. I WAS ALSO TOLD IT WAS FDA APPROVED, BUT LATER LEARNED IT IS NOT FOR THE FACE. IT IS ADVERTISED FOR ENTIRE FACE WITH NO WARNING OF NERVE DAMAGE AND FAT LOSS. I?M PHYSICALLY AND EMOTIONALLY DAMAGED. I?M SCARED OF WHAT ELSE IT?S DONE THAT CAN?T BE SEEN AS I HAVE TUGGING, VIBRATING AND ACHING FEELINGS IN FACE. I?VE BEEN TO DOCTORS MULTIPLE TIMES AND HAVE BEEN TOLD I HAVE NERVE DAMAGE AND AM SEEING A NEUROLOGIST NEXT WEEK. I?M PREGNANT NOW AND CAN'T TAKE RECOMMENDED MEDICATION FOR PAIN.