FDA.reportPublic FDA data

MAUDE MDR 6429743

MDR report key
6429743
Report number
3006560326-2017-00006
Event key
0
Event type
3
Date of event
2016-08-08
Date received
2017-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KELLIE CERVANTES-WILES
Address
1840 S STAPLEY DR # 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
1CELLFINACELLFINA STERILE DISPOSABLE KITULTHERA, INCOUPCK1UNKNOWNN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-2301. O; 2. R

Event Narratives#

N

Patient 1

ULTHERA MEDICAL DIRECTOR DISCUSSED USE OF COMPRESSIVE GARMENTS, MASSAGE, MUD-WRAPS TO ABSORB TISSUE FLUID (FOR THOSE THAT HAVE ACCESS TO THIS MODALITY) COULD BE APPLIED AS THE SOLUTION FOR PROBLEM MANAGEMENT. HOWEVER, THE PATIENT IS NOT RETURNING FOR FURTHER FOLLOW-UP. DR. (B)(6) WILL SEND THE PATIENT A LETTER ASKING HER TO RETURN AND WILL ITEMIZE PROPOSED TREATMENTS.? THE DEVICE WAS UNABLE TO BE INVESTIGATED AS IT'S A SINGLE USE DISPOSABLE. THE PRACTICE DID NOT RECORD THE LOT NUMBER, THEREFORE UNAVAILABLE FOR THIS REPORT (AS WELL AS THE UDI). IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. DEVICE DISPOSED, SINGLE USE.

D

Patient 1

ULTHERA, INC. RECEIVED A REPORT ON 2/23/2017 FROM A HEALTH CARE PROVIDER (HCP) STATING THAT A PATIENT CURRENTLY UNDER HER CARE FOR ENDERMOLOGIE TREATMENT WAS CONCERNED WITH THE RESULTS FROM THE PATIENT'S CELLFINA TREATMENT RECEIVED ON (B)(6) 2016 FROM ANOTHER PRACTICE. ULTHERA, INC. CONTACTED THE ORIGINAL HCP THAT TREATED THE PATIENT ON (B)(6) 2016 AND RECEIVED INFORMATION THAT THE CELLFINA TREATMENT FOR BUTTOCKS, POSTERIOR, LATERAL, AND ANTERIOR THIGHS WENT SMOOTHLY AND WITHOUT EVENT. THE PATIENT SAW THE ORIGINAL HCP FOR A FOLLOW-UP VISIT ON (B)(6) 2016 AND DEMONSTRATED GOOD RESULT WITH NO WARNING SIGNS. A SECOND FOLLOW-UP VISIT WAS RECOMMENDED IN (B)(6) 2016, HOWEVER THE PATIENT RESCHEDULED TO (B)(6) 2016 WHEN THE PATIENT PRESENTED WITH SOME LOCALIZED THIGHS DEFORMITIES. DURING THE (B)(6) FOLLOW-UP VISIT, THE PATIENT STATED THAT SOMETIME BETWEEN (B)(6), SHE HAD RECEIVED ENDERMOLOGIE TREATMENT WITH A DIFFERENT HCP (THE REPORTER). LATER, THE PATIENT RETRACTED THAT SHE WAS TREATED WITH ENDERMOLOGIE DURING THAT TIME. BASED ON REVIEW OF THE ORIGINAL CELLFINA TREATMENT RECORDS, INITIAL FOLLOW-UP RESULTS AND CURRENT PHOTOS, IT IS SUSPECTED THAT THE PATIENT DID RECEIVE ENDERMOLOGIE IN THE AREAS SHE ALSO RECEIVED CELLFINA TREATMENT. THE ENDERMOLOGIE TREATMENT GIVEN TO THE SAME AREAS THE CELLFINA TREATMENT COULD POTENTIALLY AGGRAVATE THE INITIAL SUBCISSIONS FROM THE CELLFINA TREATMENT CAUSING THE LOCALIZED SWELLINGS.