FDA.reportPublic FDA data

MAUDE MDR 7102869

MDR report key
7102869
Report number
3006560326-2017-00023
Event key
0
Event type
3
Date of event
2016-10-03
Date received
2017-12-10
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#

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 *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-1001. O

Event Narratives#

N

Patient 1

FOLLOWING THE INITIAL REPORT, THE TREATMENT PROVIDERS WERE CONTACTED, HOWEVER, THEY NO LONGER WORK AT THE PRACTICE AND DO NOT HAVE ACCESS TO RECORDS IN ORDER TO COMMENT. THE PRACTICE WAS CONTACTED ON (B)(6) 2017 AND (B)(6) 2017 BUT TO DATE HAS NOT PROVIDED ANY ADDITIONAL INFORMATION OR CONFIRMED AVAILABILITY OF THE DEVICE OR RECORDS ASSOCIATED TO THE DEVICE OR TREATMENT. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

ON (B)(6) 2017, A PATIENT CONTACTED ULTHERA, INC., MERZ DEVICE INNOVATION CENTER AND REPORTED PERMANENT SCARS, LOOSE SKIN, AND "CONCAVITIES" FOLLOWING AN ULTHERAPY TREATMENT ON (B)(6) 2016. THE PATIENT ALSO REPORTED UNDERGOING A PRIOR ULTHERAPY TREATMENT ON 2016-MAR-17. THE PATIENT STATED THAT SHE HAD FAT GRAFTING AND A FULL FACE AND NECK LIFT TO ADDRESS THE OUTCOMES.