MAUDE Adverse Event Report: MERZ AESTHETIC / MERZ NORTH AMERICA INC. ULTHERAPY; IMPLANT, DERMAL FOR AESTHETIC USE

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

Patient Problems Pain (1994); Tingling (2171); Therapeutic Response, Decreased (2271)

Event Date 04/23/2019

Event Type  Injury  

Event Description

I am experiencing severe pain in my right arm (elbow and shooting pain down to my wrist) after therapy to my lower face and neck on (b)(6) 2019.During the ultherapy treatment, i felt some tingling / stinging pain traveling from the right side of my neck all the way down my arm during treatment that was sufficiently severe to cause me to wince, and asked the nurse operating the machine if that was normal.She acted as though it were not unusual, and simply said that everyone's physiology is different.She said she would stop treating that area on the far right side of my lower neck for add'l passes of the machine probe.I started to experience pain in my arm approx 5 weeks post ultherapy, without recalling any acute injury to my elbow that could be responsible for the pain.Three weeks later, the pain has not resolved and has significantly worsened.Therefore i am seeking medical evaluation and treatment on (b)(6) 2019.It just occurred to me that it was the same side where i experienced the pain with ultherapy, and that it could possibly be related, particularly since i cannot recall any other injury or cause.As no testing has yet been done, it remains to be seen whether the injury is related to the ultherapy device.I am seeking treatment on (b)(6) 2019 and can update any relevant tests / data after that time.Fda safety report id# (b)(4).

• Brand Name: ULTHERAPY
• Type of Device: IMPLANT, DERMAL FOR AESTHETIC USE
• Manufacturer (Section D): MERZ AESTHETIC / MERZ NORTH AMERICA INC.
• MDR Report Key: 8615601
• MDR Text Key: 145397887
• Report Number: MW5086670
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Weight: 52