FDA Adverse Event Injury Summary report: N

ULTHERA

MDR report key: 5080787 · Received September 13, 2015

Report

Report Number
MW5056186
Event Type
Injury
Date Received
September 13, 2015
Date of Event
July 15, 2013
Report Date
September 13, 2015
Manufacturer
ULTHERA
Product Code
OHV
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAD AN 'ULTHERAPY' TREATMENT OVER 2 YEARS AGO WHICH WAS EXTREMELY PAINFUL, FELT LIKE HAMMERING ON MY FACE AND ULTIMATELY CAUSED SEVERE NERVE DAMAGE OF MY MOUTH. THE FOLLOWING MORNING OF THE PROCEDURE I COULD NOT DRINK FROM CUPS NOR PRONOUNCE THE LETTERS M, P, OR B PROPERLY. I CALLED THE DOCTOR'S OFFICE IMMEDIATELY AND WAS SEEN AT THEIR FACILITY THAT DAY, GIVEN MEDICATION AND WAS TOLD IT WOULD GO AWAY IN A COUPLE DAYS, IT DIDN'T. AT SOME POINT THE TECHNICIAN OFFERED BOTOX TO BALANCE OUT THE SEVERITY, WHICH I DECLINED. I CONTACTED ULTHERA WHO CONFIRMED THAT NERVE DAMAGE HAPPENS, BUT IT'S RARE AND THAT I WOULD NEED TO SPEAK FURTHER WITH MY DOCTOR'S OFFICE AND WAS OF NO FURTHER ASSISTANCE. EACH TIME I CONTACTED THE DOCTOR'S OFFICE I WAS TOLD IT WOULD GO AWAY; INITIALLY DAYS, THEN WEEKS, THEN FINALLY TOLD IT COULD TAKE UP TO 6 MONTHS. THE NERVE DAMAGE WAS SEVERE AND LOOKED LIKE I HAD BELLS PALSY FOR SEVERAL MONTHS AND THE DROP IN MY MOUTH WAS NOTICEABLE FOR 1.5 YEARS WHEN SPEAKING AND MY MOUTH SLANTED AT REST. I AM BETTER NOW, NOT PERFECT, THERE ARE STILL SOME ISSUES WHEN SPEAKING AND SLIGHT SLANT OF MOUTH UPON REST. I WAS ALSO NEVER INFORMED NERVE DAMAGE RISKS. I WAS TOLD I WOULD GET A SLIGHT EYELID LIFT AND THE LOOSE SKIN AROUND MY JOWLS WOULD BE GREATLY IMPROVED. THERE WAS NEVER ANY IMPROVEMENT IN VOLUME ON MY FACE, ULTIMATELY THE SKIN LOOKED MORE DEFLATED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
604647 ULTHERA ULTHERA OHV ULTHERA

Patients

Seq Age Sex Outcome Treatment
1 51 YR Other| S