MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 2; DERMAL FILLER

Model Number NOT APPLICABLE

Device Problem Output Problem (3005)

Patient Problem Foreign Body Embolism (4439)

Event Type  Injury  

Manufacturer Narrative

No corrective actions.Teoxane is monitoring similar situations.

Event Description

According to the received information from a post-market surveillance survey, following injection of teosyal rha 2 in the forehead lines, the patient presented a vascular compromise three days later.A 1cm black tissue patch was noticed.The nurse was accompanied by a doctor to manage the case.As treatment, the area was hylased (number of times unknown).Three days later, the vascular supply was restored.The doctor recommended a cream (duoderm) and oral antibiotics.4 days later, symptoms were fully resolved, without scarring.

• Brand Name: TEOSYAL RHA 2
• 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: 13169321
• MDR Text Key: 288599367
• Report Number: 3005975625-2021-00749
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: TP30L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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