MAUDE MDR 7805162

MDR report key
7805162
Report number
MW5079272
Event key
0
Event type
3
Date of event
2016-03-17
Date received
2018-08-21
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 CELLULAR DISRUPTIONMERZ NORTH AMERICA, INC.OHVI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-08-2101. R

Event Narratives#

D

Patient 1

I HAD ULTHERAPY ON (B)(6) 2016 AT (B)(6) DERMATOLOGY IN (B)(6). I WAS A PT OF DR (B)(6) FOR SEVERAL YEARS AND IT WAS HER AESTHETICIAN, (B)(6), WHO PERFORMED THE TREATMENT. AFTER THE FIRST TWO MONTHS, I BEGAN TO HAVE SIGNIFICANT LOSS OF FACIAL VOLUME. BY 6 MONTHS, I HAD EXTREME FACIAL WASTING. DUE TO MY ALARM OVER THE RESULTING SAGGING SKIN ON MY FACE AND NECK, AN ULTHERA REP RECOMMENDED A SECOND ULTHERA TREATMENT TO TIGHTEN MY SKIN. THIS SECOND TREATMENT WAS AGAIN PERFORMED BY (B)(6), UNDER THE SUPERVISION OF THE ULTHERA REP ON (B)(6) 2016. THE SECOND TREATMENT RESULTED IN FACIAL SCARRING AND SIGNIFICANT TEXTURAL DAMAGE. I HAD TO UNDERGO FACIAL REPAIR SURGERY, TO INCLUDE FAT TRANSFER, EXCESS SKIN REMOVAL, AND LASER RESURFACING. ULTHERA, THE MERZ COMPANY, HAS BEEN NOTIFIED ON A NUMBER OF LEVELS OF MY RESULTING DAMAGE, INCLUDING MY PLASTIC SURGEON'S EFFORTS TO COMMUNICATE MY DAMAGES TO ULTHERA'S FIELD EVENTS OFFICE. THE FDA APPROVED DEVICE HAS BEEN DEVASTATING AND IRREPARABLE EFFECTS IN ALL AREAS OF MY LIFE. I WILL NEVER BE THE SAME AFTER ENDURING THE SUFFERING THAT ULTHERAPY HAS BROUGHT ME AND LOVED ONES. PLEASE REMOVE THIS DEVICE FROM THE MARKET. PLEASE SAVE OTHER WOMEN FROM BEING RUINED BY ULTHERAPY.