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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3 DERMAL FILLER

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TEOXANE SA TEOSYAL RHA 3 DERMAL FILLER Back to Search Results
Model Number NOT APPLICABLE
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Ecchymosis (1818); Embolism/Embolus (4438)
Event Date 12/06/2021
Event Type  Injury  
Manufacturer Narrative
Batch number of the related product has been retrieved and quality investigations performed. The batch has been released in accordance with the manufacturers' specifications. One other complaint has been registered for this batch number to date. This complaint is not related to the present complaint.
 
Event Description
According to the information received on (b)(6) 2021, a patient was injected in the nasolabial folds on (b)(6) 2021 with teosyal rha 3. Following injection, the patient developed an embolization. A local medical expert (b)(6) was then contacted the same day by our italian affiliate in order to help in the management of the case. Another doctor (dr trocchi) supported the injector to treat the issue since the latter did not have enough hyaluronidase in her ambulatory and a worsening occured in the evening. Dr trocchi used hyaluronidase immediately on (b)(6) 2021, and the day after, additional 200iu of hyaluronidase. However, on (b)(6) 2021, the situation was not improving, so the patient received a third hyaluronidase injection (100iu). The patient had an ultrasound (unknown date) which confirmed the presence of ecchymotic effusion in the malar region and right cheek with the presence of crusty evolution. On (b)(6) 2021, the patient received a fourth hyaluronidase injection (100iu). Despite reminders, we did not receive additional information regarding symptoms evolution or any update at the time of this report.
 
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Brand NameTEOSYAL RHA 3
Type of DeviceDERMAL FILLER
Manufacturer (Section D)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
Manufacturer (Section G)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
Manufacturer Contact
nicolas caill
rue de lyon
105
geneva 1203
CH   1203
022344-963
MDR Report Key13168707
MDR Text Key284046644
Report Number3005975625-2021-00743
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P170002,
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTP27L-210722B0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/05/2022 Patient Sequence Number: 1
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