ULTHERAPY DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for ULTHERAPY DEVICE manufactured by Merz North America, Inc..

Event Text Entries

[139685990] In consulted and was examined by (b)(6), md who practices in (b)(6). Dr (b)(6) specializes in skin care and aesthetics. She prescribed standard ultherapy at depths of 3. 0mm and 4. 5mm for stimulating the production of collagen. A tech with training in ultrasound and specifically trained in the use of the merz aesthetics ultherapy device administered the prescribed treatment. This ultherapy treatment immediately caused raised lines on my skin wherever the transducer was applied. These lines were red and very swollen with black dots in each pore. I returned the next day to dr (b)(6) office and was told the redness, black dots in each pore, and raised lines would resolve in a week. However, this initial condition lasted approx three weeks. At six weeks the lines are now white, raised bumps in rows along both cheeks. They can be seen and felt. I have consulted a dermatologist and a plastic surgeon. Both physicians feel tissue below the epidermis has been permanently scarred which is the cause of the rows of bumps. They are disfiguring causing me to become depressed and too embarrassed to leave the house or meet with people. The device is still in the possession of dr (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085086
• MDR Report Key: 8444208
• Date Received: 2019-03-21
• Date of Report: 2019-03-20
• Date of Event: 2019-02-14
• Date Added to Maude: 2019-03-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: ULTHERAPY DEVICE
• Generic Name: FOCUSED ULTRASOUND FOR TISSUE HEAT
• Product Code: OHV
• Date Received: 2019-03-21
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MERZ NORTH AMERICA, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-03-21