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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTHERA, INC., MERZ DEVICE INNOVATION CENTER THE CELLFINA SYSTEM

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ULTHERA, INC., MERZ DEVICE INNOVATION CENTER THE CELLFINA SYSTEM Back to Search Results
Model Number CK-1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Scar Tissue (2060); Scarring (2061); Skin Discoloration (2074)
Event Date 02/09/2019
Event Type  Injury  
Manufacturer Narrative
An evaluation of the reported device could not be performed as it was discarded by the facility. Additional information was requested on 02-jul-2019 and 24-jul-2019. No additional information is available at this time. When additional information is received and/or investigation is completed, a supplemental report will be filed.
 
Event Description
A practice contacted merz/ulthera on (b)(6) 2019 about a patient that underwent cellfina treatment on (b)(6) 2019. The patient has allegedly experienced nodules, tenderness, discoloration, and scarring at the entry points since treatment. Additionally, the patient was allegedly "fine" immediately following treatment; however, she experienced a seizure the evening after treatment. According to the notes provided by the physician, on (b)(6) 2019: "patient called today and reports a seizure at 2 am the evening after the procedure (over 6 hours after conclusion of the procedure). She was told it was secondary to inhaled nitrous oxide used during the cellfina procedure. The patient denies b/b incontinence or t/c lacerations. The patient denies a seizure history or taking any medications. She feels improved and the discharge from the treatment area is resolved. We discussed that a seizure over six hours after nitrous oxide exposure would unlikely be related to nitrous oxide. The patient also received tumescent anesthesia with a dose of lidocaine delivered at 49 mg/kg, but denies use of any meds, including those that inhibit cyp3a4. Therefore, the reported procedure is unlikely related to the tumescent anesthesia. Patient discharged post-procedure in stable and ambulatory condition w/o any features of lidocaine toxicity including: dizziness, drowsiness, ams, tinnitus, or circumoral numbness. Patient underwent the cellfina procedure on (b)(6) 2019 and now returns for follow-up. She reports painful nodules in the lle and gluteal area. On exam, she has no palpable nodules in the gluteal area but does have two palpable and tender nodules in the left medial thigh, largest measuring approximately 1. 1cm in diameter. Patient feels the cellulite is worse. Photos taken and before/after photos reviewed with the patient today revealing improved cellulite. Surgeon who told the patient the seizure occuring in the early morning post-cellfina was due to a lidocaine overdose. We reviewed the medical record with the patient today, specifically the amount of tumescent lidocaine delivered during the procedure, which was 49 mg/kg, which is well within the accepted safe standard of care for tumescent lidocaine. Therefore, there was no overdose but rather was carefully and appropriately dosed, we discussed that it is possible that the seizure was due to lidocaine, but not due to improper dosing. " additional information was provided by the practice on (b)(6) 2019, including patient notes provided by the practice. Within notes dated (b)(6) 2019, the physician noted: "since the recent follow-up on (b)(6) 2019, the patient notes improvement in areas of tenderness and nodularity. She notes she is not shaving due to concern of entry site discolorations. " within notes dated (b)(6) 2019, the physician noted: "still has scars at sites of injection/cutting. Cleaned with hibiclens. Ablative laser ipixel @1200 for 2 passes per scar today. Advised to keep clean and stay out of sun. " within notes dated (b)(6) 2019, the physician noted: "one month post ablative laser for scar. Still concerned with scars and also feels like she still has cellulite, especially on buttocks. " the patient was treated with cellfina on the buttocks and thighs and has no prior history of cellfina treatments. The treatment lasted four hours, and a total of 114 releases were performed at a depth of 6mm. The physician stated that the device worked as intended and no malfunctions occurred during treatment. No additional information is available at this time.
 
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Brand NameTHE CELLFINA SYSTEM
Type of DeviceCELLFINA SYSTEM
Manufacturer (Section D)
ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
1840 south stapley drive
suite 200
mesa AZ 85204
Manufacturer (Section G)
ULTHERA, INC., MERZ DEVICE INNOVATION CENTER
1840 south stapley drive
suite 200
mesa AZ 85204
Manufacturer Contact
jessica ciotti
1840 south stapley drive
suite 200
mesa, AZ 85204
4808288875
MDR Report Key8822589
MDR Text Key152088371
Report Number3006560326-2019-00014
Device Sequence Number1
Product Code OUP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161885
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCK-1
Device Catalogue Number5036030
Device Lot Number2018011204
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/24/2019 Patient Sequence Number: 1
Treatment
PRONOX (NITROUS OXIDE); TUMESCENT LIDOCAINE (49 MG/KG TOTAL)
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