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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
Model Number NOT APPLICABLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angioedema (4536)
Event Date 09/07/2021
Event Type  Injury  
Manufacturer Narrative
Additional mfr narrative: analysis of batch records for the concerned lot number was conducted to test for specification and sterility compliance. Results show that this teosyal product was fully compliant.
 
Event Description
A patient was injected on (b)(6) 2021 with teosyal rha 2 in the lips ((b)(4)). She was also injected on (b)(6) 2021 once more with teosyal puresense ultra deep in the zygomatic malars ((b)(4)) and teosyal rha 4 in the zygomatic malars and soof ((b)(4)). Starting on (b)(6)2021, the patient developed severe edema, induration, redness, with sensation of heat, appearing at all injection sites. She then develops angioedema. Initial treatments included a regimen of oral corticosteroids, antihistamines and antibiotic therapy. Afterwards, redness of the chin area has decreased but the edema and induration persist both in the chin and in the rest of the areas. We received confirmation of the angioedema diagnosis on (b)(6) 2021, which updated the reportability of this case. On (b)(6)2021, we received confirmation of the complete resolution of the adverse event.
 
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Brand NameTEOSYAL RHA 2
Type of DeviceDERMAL FILLER
Manufacturer (Section D)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
MDR Report Key12646833
MDR Text Key281398713
Report Number3005975625-2021-00559
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
Source Type foreign,health professional
Type of Report Initial
Report Date 10/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2021
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTP30L-194611A0
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/18/2021 Patient Sequence Number: 1
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