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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; DERMAL FILLER
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TEOXANE SA TEOSYAL RHA 2; DERMAL FILLER Back to Search Results
Lot Number TP30L-202811B0
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Embolism (4439)
Event Date 01/25/2022
Event Type  Injury  
Event Description
According to the received information, a patient was injected with an unknown amount of rha 2 in the lips on (b)(6) 2022.On (b)(6) 2022, it was reported that the patient had symptoms of occlusion, white heads like pustules and hematoma right under the boarder of the lips (inside and outside the lips).The patient also added that the lips were sore.No treatment was provided this same day but it was planned that the patient would be reviewed in the evening.No addiditional information was available at the time of this report.
 
Manufacturer Narrative
Additional mfr narrative: this case seems linked to a vacsular occlusion.Rationale of the event will be provided in the finla report.
 
Manufacturer Narrative
This case seems linked to a vacsular occlusion.Rationale of the event will be provided in the finla report.
 
Event Description
According to the received information, a patient was injected with an unknown amount of rha 2 in the lips on (b)(6) 2022.On (b)(6) 2022, it was reported that the patient had symptoms of occlusion, white heads like pustules and hematoma right under the boarder of the lips (inside and outside the lips).The patient also added that the lips were sore.No treatment was provided this same day but it was planned that the patient would be reviewed in the evening.No addiditional information was available at the time of this report.
 
Event Description
According to the received information, a patient was injected with 0.2 ml of rha 2 in the lips on (b)(6) 2022.On (b)(6) 2022, it was reported that the patient had symptoms of occlusion, with white heads like pustules and hematoma right under the boarder of the lips (inside and outside the lips).The patient also added that the lips were sore.No treatment was provided this same day but it was planned that the patient would be reviewed in the evening.Eventually on an unknown date, the patient was prescribed aspirin, antibiotics (cephalexin) warm compresses and antiviral drug, which led to complete resolution of the symptoms without sequelae.No skin break down or necrotic tissue developed.
 
Manufacturer Narrative
Additional mfr narrative: this case seems linked to a vacsular occlusion.Vascular complications are rare serious side effects, although widely known and documented in the context of filler injections.They are related to the accidental injection of the product inside or close to a blood vessel, leading to its occlusion or compression, blocking the blood flow.If treated on time with an appropriate treatment, symptoms can be fully resolved without sequalae.If the vascular complication is not detected/diagnosed and treated timely, it can lead to a skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
 
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Brand Name
TEOSYAL RHA 2
Type of Device
DERMAL 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 Key13599553
MDR Text Key286141061
Report Number3005975625-2022-00059
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Lot NumberTP30L-202811B0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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