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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Granuloma (1876)
Event Type  Injury  
Event Description
According to the received information, the patient was injected with an unknown amount of teosyal rha 3 in the lips in (b)(6) 2021.On an unknown date, the patient noticed a granuloma on the lip.On (b)(6) 2022, symptoms were still ongoing and it was unknown if a treatment had been given to the patient.Despite reminders, no additional information could be retrieved at the time of this report.
 
Manufacturer Narrative
Additional mfr narrative: granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.Appropriate medical treatment generally allows to treat these reactions quickly and effectively the risk of such reaction is mentioned in the instructions for use of teosyal products.
 
Event Description
According to the received information, the patient was injected with an unknown amount of rha 3 in the lips in december 2021.On an unknown date, the patient noticed a granuloma on the lip.On 10 march 2022, symptoms were still ongoing and it was unknown if a treatment had been given to the patient.Despite reminders, no additional information could be retrieved at the time of this report therefore complaint was closed as is.
 
Event Description
According to the received information, the patient was injected with an unknown amount of rha 3 in the lips in (b)(6) 2021.On an unknown date, the patient noticed a granuloma on the lip.On (b)(6) 2022, symptoms were still ongoing and it was unknown if a treatment had been given to the patient.Despite reminders, no additional information could be retrieved at the time of this report therefore complaint was closed as is.
 
Manufacturer Narrative
Additional mfr narrative: granulomas are known and widely documented effects in the context of hyaluronic acid filler injections.They are caused by a delayed immune reaction of the body in response to the implant being treated as a foreign body.As it is unable to eliminate the implant, the body surrounds it with immune cells (macrophages) forming a more or less hard and inflammatory mass.Appropriate medical treatment generally allows to treat these reactions quickly and effectively the risk of such reaction is mentioned in the instructions for use of teosyal products.
 
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Brand Name
TEOSYAL RHA 3
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 Key14039782
MDR Text Key288775229
Report Number3005975625-2022-00138
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,Followup
Report Date 11/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTP27L- 211116A0
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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