MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3; DERMAL FILLER

Model Number NOT APPLICABLE

Device Problem Missing Information (4053)

Patient Problem Foreign Body Embolism (4439)

Event Type  Injury  

Event Description

According to the information received on 18-nov-2021 from an injector, a patient was injected on an unknown date with a teosyal rha 3 product to an unknown site.On an unknown exact date in (b)(6) 2020, the patient experienced a vascular compression.Despite several attempts, no further information could be obtained regarding the treatment initiated, the resolution of the event or the batch number.Therefore, the case will be closed as is.

• Brand Name: TEOSYAL RHA 3
• Type of Device: DERMAL 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 Key: 13010151
• MDR Text Key: 282270260
• Report Number: 3005975625-2021-00707
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female