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

Model Number CK-1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

Attempts to contact the doctor to gather additional information regarding the event and if a device malfunction occurred during treatment were performed on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019; however, no additional information was provided.A review of the shipping history indicated multiple cellfina systems were shipped to this customer, but it is unknown what device was used during treatment on this patient.As information linking the alleged scarring to a particular device, kit, or malfunction is not possible, device identification and evaluation cannot be performed.A review of the patient complaint trend analysis for the reported issue of "scar" found this condition has not occurred at a high enough frequency level to provide a signal at this time and will continue to be monitored.Although the initial information for this event was provided directly from the patient who received treatment, the treating office is listed as they were the appropriate contact for follow-up.Should additional information regarding this event become available, a supplemental medwatch will be filed.

Event Description

A patient alleged on (b)(6) 2019 that six months following cellfina treatment, she had 34 dark scars on the treatment spots of her buttocks and thighs.The patient attributed it to her skin type and alleged informing the doctor that her skin scars differently, but was reassured that the procedure would not scar.The patient reported having a laser procedure following the cellfina treatment in an attempt to reduce the visibility of the scars, but the scars became worse after the treatment.The patient also reported having previous liposuction performed in the area.The patient does not believe any malfunction occurred or that the procedure went wrong.Attempts to contact the doctor to gather additional information regarding the event occurred on (b)(6) 2019, (b)(6) 2019, and (b)(6) 2019; however, 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
• Manufacturer (Section G): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• Manufacturer Contact: jessica ward dykstra ; 1840 south stapley drive; suite 200; mesa, AZ 85204 ; 4803361457
• MDR Report Key: 8596501
• MDR Text Key: 144595106
• Report Number: 3006560326-2019-00008
• Device Sequence Number: 1
• Product Code: OUP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CK-1
• Device Catalogue Number: 5036030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other