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

Model Number NOT APPLICABLE

Device Problem Output Problem (3005)

Patient Problem Skin Infection (4544)

Event Date 09/30/2021

Event Type  Injury  

Event Description

According to the received information, the patient was injected with 2 vials of rha 3 in the forehead and pre jowl areas on both sides on (b)(6) 2021.On (b)(6) 2021, the patient started to feel "balls" and hardness.On (b)(6) 2021, the injector reported that on palpation, the area felt much larger than the product injected.A localized infection was suspected so the patient was treated with antibiotics and metrol dose pack for two weeks.If the situation is not improved in two weeks, the injector plans to dissolve the product with hyaluronidase.No additional information is available at the time of this report.

Manufacturer Narrative

Additional mfr narrative: additional infromation has been queried to perform investigations.

Manufacturer Narrative

Additional mfr narrative: delayed inflammatory reactions that manifest as swelling, firmness and nodules, are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.Their aetiologies are numerous.They may be related to an immune response of the body to the implant or to a bacterial infection, as suspected in this case.Infections can happen after an injection with an improper technique, inducing a lack of asepsis of the injection environment, which in some case may result in sepsis.External factors, such as the use of makeup immediately after the injection, can also increase the risk of skin infection.With appropriate 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, the patient was injected with 2 vials of rha 3 in the forehead and pre jowl areas on both sides on (b)(6) 2021.On (b)(6) 2021, the patient started to feel "balls" and hardness.On (b)(6) 2021, the injector reported that on palpation, the area felt much larger than the product injected.A localized infection was suspected so the patient was treated with antibiotics and metrol dose pack for two weeks.If the situation did not improve in two weeks, the injector planned to dissolve the product with hyaluronidase.Despite follow-ups,no additional information could be retrieved at the time of this report.

• 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: 13042316
• MDR Text Key: 285847850
• Report Number: 3005975625-2021-00715
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• 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: TP27L-211116A0
• 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