FDA.reportPublic FDA data

MAUDE MDR 8391471

MDR report key
8391471
Report number
3006560326-2019-00001
Event key
0
Event type
3
Date received
2019-03-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. JESSICA WARD DYKSTRA
Address
1840 SOUTH STAPLEY DRIVE SUITE 200 MESA AZ 85204 US
Phone
480-480-4803
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTHERA SYSTEMULTHERA SYSTEMULTHERA, INC., MERZ DEVICE INNOVATION CENTEROHVUC-1UC-1N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-0501. S

Event Narratives#

N

Patient 1

NO CONTACT DETAILS FOR THE REPORTER ARE AVAILABLE, AND RECORDS SHOW THAT THE COMPLAINANT HAS NOT ATTEMPTED TO REACH OUT TO REPORT THIS EVENT DESPITE THE SOCIAL MEDIA MONITORING AGENCY PROVIDING THEM WITH ULTHERA'S CONTACT DETAILS. THE PROVIDER MENTIONED IN THE POST WAS CONTACTED TWICE BY PHONE, THE FIRST TIME WITH THE PATIENT'S INITIALS (14-FEB-2019) AND THE SECOND WITH THE PATIENT'S FULL NAME (18-FEB-2019), AND WAS NOT ABLE TO CONFIRM TREATMENT OR KNOWLEDGE OF THE PATIENT. AS ADDITIONAL INFORMATION WAS NOT OBTAINED, DEVICE IDENTIFICATION, DEVICE EVALUATION, AND SUPPORT LOG REVIEW CANNOT BE PERFORMED. THE REPORT CONTAINS NO ALLEGATION OF A MALFUNCTION AND ONE CANNOT BE CONFIRMED. THERE IS NOT ENOUGH INFORMATION TO CONFIRM WHETHER A DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE REPORT OF "DENT" WAS CAPTURED AS TISSUE DAMAGE FOR THE PATIENT PROBLEM CODE IN THE INTEREST OF CAPTURING THE REPORTED ISSUE BUT IN THE ABSENCE OF A FORMAL DIAGNOSIS. SHOULD ADDITIONAL INFORMATION REGARDING THIS EVENT BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

A SOCIAL MEDIA MONITORING AGENCY REPORTED VIA E-MAIL ON 2/5/2019 THAT A PATIENT ALLEGED "ULTHERAPY CAUSED A PERMANENT DENT NEAR MY EYE. I WON AN (B)(6) VALUE DOOR PRIZE FROM (B)(6) DERMATOLOGY AND LEFT WITH ZERO RESULTS AND A NOTICEABLE DENT" VIA (B)(6) POST. NO FURTHER INFORMATION WAS OBTAINED.