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

Model Number CK1 - EU

Device Problem Insufficient Information (3190)

Patient Problem Deformity/ Disfigurement (2360)

Event Date 04/27/2019

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device used during treatment is available for investigation.The device information for the cellfina disposable kit used during treatment is currently unknown.No additional information is available at this time.When additional information is received, a supplemental report will be filed.

Event Description

On 22-aug-2019, a physician reported to a merz affiliate information regarding a cellfina adverse event.The physician reported that a patient presented with "dermal protrusions on the treatment site" following a cellfina treatment on (b)(6) 2019.The symptoms were still present three months post-treatment.On 02-sep-2019, additional information was provided by the physician stating, ".Protrusions that do not disappear after 3 months of treatment and a significant disability." no additional information is available at this time.

Manufacturer Narrative

Attempts to acquire additional information were made on 27-aug-2019, 10-sep-2019, and 13-sep-2019.The practice did not return the device used for treatment or provide a lot number for the disposables kit used for treatment.As such, a lot complaint history review and lot history record review could not be performed for the disposables kit used for this treatment.A review of the cellfina patient complaint trending analysis for the reported issue of skin surface convexity, depression, or other irregularity found that the issue has not occurred at a high enough frequency to generate a trend and will continue to be monitored.As the physician stated the cellfina devices performed as intended during treatment and no evidence of a device malfunction was identified during the patient investigation, it is unknown if a cellfina device caused or contributed to the event.However, a contributory role to the treatment with the cellfina system cannot be excluded with certainty.No additional information is available at this time.If additional information is received, a supplemental medwatch form will be submitted.

Event Description

Additional information was provided by the merz affiliate regarding this cellfina treatment.It was alleged that this young female patient was treated on the gluteal region and posterior/lateral regions of the thigh with approximately 40 or more releases at depths of 9mm, 10mm, and 6mm using the teardrop platform.The treatment lasted two hours and following treatment the patient was instructed to use compression and sanitary disposable pads for two to three days.This patient's bmi was less than 25 at the time of treatment.The treatment was performed by a physician who has been trained on the cellfina system, but has allegedly performed few treatments.The anesthesia used during treatment contained 1% lidocaine; equating to 50 ml.The patient was scheduled for a three month follow-up visit post-treatment.This was the patient's first cellfina treatment and no other cosmetic procedures were reported to have been performed on the treatment area.It was reported that the equipment performed as intended for this treatment and no intervention was performed following conclusion of the procedure.The affiliate reported that the components of the disposables kit used for treatment are not available for return.No additional information is available at this time.

• Brand Name: THE CELLFINA SYSTEM
• Type of Device: CELLFINA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 9077594
• MDR Text Key: 163088269
• Report Number: 3006560326-2019-00022
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• PMA/PMN Number: K161885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CK1 - EU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: LIDOCAINE (1%)
• Patient Outcome(s): Other