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U.S. Department of Health and Human Services

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

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TEOXANE SA TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL Back to Search Results
Model Number TEOSYAL
Device Problem Ejection Problem (4009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/22/2019
Event Type  malfunction  
Manufacturer Narrative
Such event is known and generally caused by a failure to comply with the needle-syringe assembly directions, which are mentioned in the instructions for use. The design of the product, with a built-in luer lock and a double screw tread needle-syringe connection, makes needle disconnection/ejection unlikely to occur as long as the user safely screwed the needle onto the syringe.
 
Event Description
The event happened outside of the u. S, in the (b)(6). According to the received information, when using the syringe to inject the patient with the provided needles, the practitioner experienced a needle ejection. No consequence for either the patient or the practitioner was reported. This event is reported considering the possibility that a recurrence of this type of issue can cause a serious injury, despite not being the case here.
 
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Brand NameTEOSYAL RHA 4
Type of DeviceHYALURONIC ACID DERMAL FILLER GEL
Manufacturer (Section D)
TEOXANE SA
rue de lyon, 105
geneva, CH-12 03
SZ CH-1203
Manufacturer (Section G)
SAME AS CONTACT OFFICE
Manufacturer Contact
emilie macé
rue de lyon, 105
geneva, CH-12-03
SZ   CH-1203
MDR Report Key8603765
MDR Text Key144977230
Report Number3005975625-2019-00012
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 health professional
Type of Report Initial
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Model NumberTEOSYAL
Device Catalogue NumberRHA 4
Device Lot NumberTPUL-183511A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2018
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: 05/13/2019 Patient Sequence Number: 1
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