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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3; HYALURIONIC ACID DERMAL FILLER GEL
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TEOXANE SA TEOSYAL RHA 3; HYALURIONIC ACID DERMAL FILLER GEL Back to Search Results
Model Number NOT APPLICABLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Granuloma (1876)
Event Date 09/26/2020
Event Type  Injury  
Event Description
This event happened outside the united states in (b)(6).According to the received information, the patient was injected with teosyal rha 3 in glabella, in the nasolabial folds, in the oral commissure and the upper lip on the (b)(6) 2020.On 2020-09-26 the injector reported that the patient presented a granuloma in the glabella.The intensity is reported as severe.A second granuloma appeared on (b)(6) 2020 (medium intensity) and a third one in the marionettes lines on (b)(6) 2020 (low intensity) a biopsy has been carried out and the diagnosis of granuloma was confirmed.
 
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Brand Name
TEOSYAL RHA 3
Type of Device
HYALURIONIC ACID DERMAL FILLER GEL
Manufacturer (Section D)
TEOXANE SA
rue de lyon, 105
geneva, CH 12 03
SZ  CH 1203
Manufacturer Contact
fiona di folco
rue de lyon, 105
geneva, CH-12-03
SZ   CH-1203
MDR Report Key10939999
MDR Text Key219320168
Report Number3005975625-2020-00034
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
PMA/PMN Number
P170002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTP27L-193412A
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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 Age52 YR
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