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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 Foreign Body Embolism (4439)
Event Date 02/01/2022
Event Type  Injury  
Event Description
This case occured outside of the united states, in (b)(6).On 01-feb-2022, a patient was injected in the chin with a puresense ultradeep (complaint (b)(4)) and rha 3 product.The following day, the patient presented with blanching and bruising in the chin, diagnosed as vascular occlusion.The patient was treated with hyaluronidase and was prescribed steroids, antibiotics and an antiviral.In addition, the patient was sent to a hyperbaric chamber.She since made a full recovery and did not require any further medical care.
 
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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 Contact
nicolas caill
rue de lyon
105
geneva 1203
CH   1203
022344-963
MDR Report Key13730585
MDR Text Key291729262
Report Number3005975625-2022-00074
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2022
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-212628C0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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;
Patient SexFemale
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