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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4 DERMAL FILLER

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TEOXANE SA TEOSYAL RHA 4 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
According to the information received, this case seems to be an angioedema which is a well-known and documented adverse effect of dermal fillers. Additionally, the risk of such adverse event is also mentioned in the instructions for use of our products. Batch analyses undertaken confirms that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed.
 
Event Description
According to the received information, the patient was injected on (b)(6) 2021 with teosyal rha 2 in the lips (rc/2109083). She was also injected on (b)(6) 2021 with teosyal puresense ultra deep in the zygomatic malars (rc/2109084) and teosyal rha 4 in the zygomatic malars and soof (rc/2109085). Starting on (b)(6) 2021, the patient developed severe edema, induration, redness, with sensation of heat, appearing at all injection sites. She then developed an angioedema. Initial treatments included a regimen of oral corticosteroids, antihistamines and antibiotic therapy. Afterwards, redness of the chin area decreased but the edema and induration persisted both in the chin and in the other injected areas. The diagnosis of angioedema was confirmed on (b)(6) 2021, which updated the reportability of this case. On 04 october 2021, we received confirmation about the complete resolution of the adverse event.
 
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Brand NameTEOSYAL RHA 4
Type of DeviceDERMAL 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 Key12727471
MDR Text Key279273257
Report Number3005975625-2021-00560
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
P170002,
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNOT APPLICABLE
Device Catalogue NumberNOT APPLICABLE
Device Lot NumberTPUL-205021A0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2021 Patient Sequence Number: 1
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