Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANTEIS S.A. BELOTERO BLANCE; IMPLANT, DERMAL, FOR AESTHETIC USE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ANTEIS S.A. BELOTERO BLANCE; IMPLANT, DERMAL, FOR AESTHETIC USE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Injection Site Reaction (4562)
Event Type  Injury  
Manufacturer Narrative
This case was assessed as reportable to the fda as the event, bilateral lower lid painless firm masses (injection site induration), was deemed to meet the serious injury criteria of necessitated medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.The device history record for belotero could not be reviewed as the lot number was not reported.Citation: shirin hamed-azzam, md, cat burkat, md facs, abed mukari, md, daniel briscoe, md, narish joshi, md frcophth, richard scawn, md frcophth, eran alon, md, morris hartstein, md facs, filler migration to the orbit, aesthetic surgery journal, , sjaa264, https://doi.Org/10.1093/asj/sjaa264.
 
Event Description
This case is related to mdr 3013840437-2020-00094 and mdr 3013840437-2020-00095, referring to the same patient.This case is related to mdr 3013840437-2020-00083, mdr 3013840437-2020-00084, mdr 3013840437-2020-00085, mdr 3013840437-2020-00086, 3013840437-2020-00087, 3013840437-2020-00088, mdr 3013840437-2020-00089, mdr 3013840437-2020-00090, mdr 3013840437-2020-00091, mdr 3013840437-2020-00092, and mdr 3013840437-2020-00093, referring to the same literature article.This is a literature report from a retrospective, multicenter analysis performed on patients who underwent dermal filler injection to the face with subsequent orbital complications.This literature report from israel, concerns a (b)(6)-year-old female patient.She was injected with hyaluronic acid, into the jawline and cheeks.The patient was previously injected with dermal filler, into the face.Eighteen months after the treatment with hyaluronic acid, the patient presented with bilateral lower lid painless firm masses that migrated to the orbit, further described as located on the inferior orbital.Upon questioning, she admitted that she performed extensive facial massage for months, as she palpated multiple bumps in her jawline.A computed tomography scan showed a mass anterior to the lower right rim with extension to the anterior orbit.Orbital surgery with excisional biopsy was proposed; however, the patient preferred an attempt of hyaluronidase injection.As reported, the patient refused surgery.The patient was injected with 1500 units of hyaluronidase.Hyaluronidase was reconstituted in 1 ml of normal saline.A total of 0.1 ml of this mixture was then further[ diluted in 1 ml of saline and then injected, where possible directly into the mass.A second injection was carried out 2-3 weeks later.The two rounds of hyaluronidase injections were performed with subtotal resolution of the mass after 2 months of follow-up.As reported, the author was still awaiting for the patients decision regarding further intervention.Due to the provided information, the outcome of the event bilateral lower lid painless firm masses, was considered as resolving.The outcome of the event filler migration to the orbit, was unknown.In the opinion of the authors, orbital complications secondary to migrated filler may occur long after the initial procedure.Since the site of the complication is distant from the injection site, patients and physicians may not immediately make the connection.This may lead to unnecessary examinations and a delay in diagnosis while looking for standard orbital masses.Dermal fillers should be considered in the differential diagnosis of patients presenting with a new onset orbital masses.This may lead to a delay in diagnosis and excessive and unnecessary examinations.So far, there is a lack of understanding as to precise mechanism how the filler migrated to the orbit.The authors suggest post-injection massage with subsequent delayed symptomatic, high volumes of injected filler, facial muscle activity and pressure-induced migration as possible explanations.
 
Event Description
Follow-up information was received on 13-nov-2020: the reporter informed that it was a retrospective research and it was not know which company was used, as they did not inject the fillers.The outcome of the events remained unchanged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BELOTERO BLANCE
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 Key10646717
MDR Text Key210406571
Report Number3013840437-2020-00096
Device Sequence Number1
Product Code LMH
Combination Product (y/n)Y
PMA/PMN Number
P090016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 12/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Date Manufacturer Received11/13/2020
Patient Sequence Number1
Treatment
CONCOMITANT DRUG NOT AVAILABLE.; CONCOMITANT DRUG NOT AVAILABLE.
Patient Outcome(s) Required Intervention;
Patient Age64 YR
-
-