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

Model Number UC-1

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cellulitis (1768); Edema (1820); Burning Sensation (2146); Patient Problem/Medical Problem (2688)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch report will be submitted.

Event Description

On (b)(6) 2017 a (b)(6) field representative received an email making them aware of a female patient who received an ultherapy treatment on (b)(6) 2016 with device serial number (b)(4).Patient alleges that as a result of the treatment, she developed left-sided severe edema, erythema, and discomfort starting in the chest wall and moving up the left side of her neck.Patient sought medical treatment on (b)(6) 2016 for neck stiffness, redness and warmth.Subsequent blood tests revealed elevated white blood cell count.A ct scan (date unknown) demonstrated extensive myositis and intramuscular edema.Patient alleges that she experienced a disruption of the integrity of her skin leading to a bacterial infiltration along the muscle and skin levels causing a myositis and cellulitis and a third-degree burn.

Manufacturer Narrative

Corrected information (d10): handpiece component of the system was returned to the manufacturer on (b)(6) 2018, and not on (b)(6) 2017.The handpiece was returned for service and repair on (b)(6)2018, and an evaluation of the returned handpiece was performed.No warning messages occurred during evaluation and the handpiece passed all tests.A review of the support log found two warning messages, a code w (unauthorized transducer) and a code j (handpiece communication halted), occurred on the treatment date.Delivery of treatment is not possible during these warning messages, and neither warning message recurred within six months after the treatment date.A review of the original device history records for the control unit and handpiece found that both devices met all requirements prior to release.A review of the original device history records for all transducers related to this report met all requirements prior to release.An evaluation of the service history for the control unit and handpiece revealed both devices were initially distributed on 18-dec-2015 and had not been returned for any service or repair evaluations prior to this event.A review of the cellfina patient complaint trend analysis revealed the conditions of "edema" and "burns" are within allowable limits and will continue to be monitored.A review of the cellfina product complaint trend analysis revealed the condition of code j is within the allowable limit and will continue to be monitored and the condition of code w has exceeded the allowable limit.A capa has been opened to investigate the issue.The patient investigation found there are not enough details to confirm if the merz/ulthera device(s) caused or contributed to this event.No additional information is available at this time.Should additional information be provided, a supplemental medwatch will be filed.

• Brand Name: ULTHERA SYSTEM
• Type of Device: ULTHERA SYSTEM
• Manufacturer (Section D): ULTHERA, INC., MERZ DEVICE INNOVATION CENTER; 1840 south stapley drive; suite 200; mesa AZ 85204
• MDR Report Key: 6742770
• MDR Text Key: 80987777
• Report Number: 3006560326-2017-00011
• Device Sequence Number: 1
• Product Code: OHV
• UDI-Device Identifier: 00840763100230
• UDI-Public: 00840763100230
• Combination Product (y/n): N
• PMA/PMN Number: K134032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UC-1
• Device Catalogue Number: UC-1
• Device Lot Number: 15C112323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other