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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3 HYALURONIC ACID DERMALL FILLER GEL

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TEOXANE SA TEOSYAL RHA 3 HYALURONIC ACID DERMALL FILLER GEL Back to Search Results
Model Number NOT APPLICABLE
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Angioedema (4536)
Event Date 09/01/2021
Event Type  Injury  
Manufacturer Narrative
Localized allergic reactions that occur through immediate oedema are well-known and documented reactions in hyaluronic acid injections. With medical treatment, symptoms can be quickly fully resolved, without sequelae. In addition, the risk of such reactions is mentioned in the instructions for use of teosyal products.
 
Event Description
According to the received information, on 1st of september the patient was injected with a rha 3 product in the upper lip. On a unknown date the patient experienced an angioedema on the upper lip. On 2nd of september, she was treated with hyaluronidase. Despite several reminders, no further information could have been obtained regarding the evolution of the symptoms.
 
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Brand NameTEOSYAL RHA 3
Type of DeviceHYALURONIC ACID DERMALL FILLER GEL
Manufacturer (Section D)
TEOXANE SA
rue de lyon 105
gevena, CH120 3
SZ CH1203
Manufacturer (Section G)
SAME AS CONTACT OFFICE
same as contact office
Manufacturer Contact
fiona di folco
rue de lyon 105
geneva, CH120-3
SZ   CH1203
MDR Report Key12546258
MDR Text Key273993103
Report Number3005975625-2021-00515
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 Nurse Practitioner
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
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 NumberTP27L-203414A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2020
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: 09/29/2021 Patient Sequence Number: 1
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