MAUDE Adverse Event Report: ANTEIS S.A. BELOTERO BALANCE; IMPLANT, DERMAL, FOR AESTHETIC USE

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

Patient Problems Necrosis (1971); Scarring (2061); Partial thickness (Second Degree) Burn (2694)

Event Type  Injury  

Manufacturer Narrative

This case was assessed as reportable to the fda as the event, necrosis, was deemed to meet serious injury criteria of necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record could not be reviewed as the lot number was not reported.Citation: perils of dermal fillers, webster, james, british journal of oral and maxillofacial surgery, volume 57, issue 10, e5 - e6.

Event Description

This case was linked to 3013840437-2020-00012, referring to the same literature article.This literature report from uk concerns a (b)(6) male patient.He was treated with a mixed hyaluronic acid and calcium hydroxyapatite injectable filler (intentional device misuse).After the mixed injection, the patient developed skin necrosis.The outcome of the event was not reported.In the opinion of the author, skin necrosis is one of the most severe complications of filler injections.Mixing filler materials to achieve more ideal filler characteristics is confounding the reversal process and hence when complications arise, they are more likely to progress to skin necrosis.

Manufacturer Narrative

Follow up attempts to obtain an updated support log containing the exam log from date of reported treatment from the affiliate were not successful, and no response was given regarding device availability for evaluation.The serial numbers of the ulthera system control unit, hand piece, and transducers used during treatment were provided.A review of the service history for the ulthera control unit revealed this device has not been sent in for service since its initial distribution.A review of the service history for the reported ulthera hand piece revealed this device has been serviced four times since its initial distribution; however, there were no relevant findings that could have contributed to this reported adverse event.An evaluation of the original device history records (dhrs) for the ulthera system control unit, handpiece, and transducer (serial number: (b)(6)) revealed no non-conformances, deviations, or rework were associated with the manufacture of these devices, and all required testing was passed prior to distribution.An evaluation of the original dhr for transducer (serial number: (b)(6)) revealed no non-conformances, deviations, or rework was associated with the manufacture of this device.One diagnostic test failed due to a communication error; however, this test was re-run with no rework required and passed on the second attempt.All other required tests were passed prior to distribution.A review of the current ultherapy patient complaint trending analysis for the reported issues of "burn" and "erythema" revealed both trends are within allowable limits and will continue to be monitored.A review of the support log provided revealed a code m was encountered by the ulthera system on the date of treatment; however, the transducer found to be related to this code was not used during this treatment per information provided.Furthermore, the affiliate reported that the ulthera equipment performed as intended and no malfunctions were identified during the treatment.Based on this information, it is not suspected that the identified code m occurred during this treatment.As the practice stated the devices performed as intended during treatment and no evidence of a device malfunction during treatment was identified during this investigation, it is unconfirmed whether a merz/ulthera device caused or contributed to the event.However, a contributory role to the treatment with this ulthera system cannot be excluded without certainty.No further information is available for this case at this time.If additional information is received, a supplemental medwatch form will be submitted.

• Brand Name: BELOTERO BALANCE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ANTEIS S.A.; 18, chemin des aulx; 1228 plan-les-ouates; geneva, ; SZ
• MDR Report Key: 9616669
• MDR Text Key: 178124927
• Report Number: 3013840437-2020-00011
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P090016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Date Manufacturer Received: 12/23/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR