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

Model Number NOT APPLICABLE

Device Problem Contamination (1120)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Swelling (2091)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

Delayed inflammatory reactions of infectious origin,at the injection site are well known and described adverse reactions following hyaluronic acid based dermal filler injections. They are usually treated adequately with no sequelae. The risk of such adverse reactions is mentioned in our product instructions for use. Bibliography: de boulle k, heydenrych i. Patient factors influencing dermal filler complications: prevention, assessment, and treatment. Clin cosmet investig dermatol. 2015;8:205-14. Signorini, m. , et al. (2016). "global aesthetics consensus: avoidance and management of complications from hyaluronic acid fillers-evidence- and opinion-based review and consensus recommendations. " plastic and reconstructive surgery 137(6): 961e-971e.

Event Description

The described event happened outside the u. S. , in (b)(6). According to the received information, 1 months after the injection of teosyal rha4 in the cheekbones area, on (b)(6) 2019, the patient presented with a pain of mild intensity in the left cheekbone, without any inflammation or heat in the area. On (b)(6) 2019, the patient presented with an inflammation of the left zygomatic area, with pain when touching. On (b)(6) 2019-, the skin swelling in the area was still ongoing. On 2019-07-31, the diagnosis of skin infection has been established for this patient. On 2019-08-28, we learned that the patient situation has been worsening during hollidays and that she went to emergency where a biopsy was done. No information has been provided on the conclusion of the biopsy. On 2019-09-05, we learned that the patient has been drained again and the wound has been left open with a drain. For the injector this issue is due to a biofilm formation. After that the patient never come back to its injector and no updated information was provided.

• Brand Name: TEOSYAL RHA 4
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: emilie macé ; rue de lyon, 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 9290895
• MDR Text Key: 179610388
• Report Number: 3005975625-2019-00022
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/31/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-190325C
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/07/2019 Patient Sequence Number: 1