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

Lot Number	22482JL0
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Dyspnea (1816)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) notified teoxane of an adverse event on 10-jul-2024.The patient was injected on (b)(6) 2024 with: 1 ml of rha redensity in the perioral lines.The injection was done with a 31g needle (complaint (b)(4).1.2 ml of rha 4 in the cheekbone.The injection was done with a 27g needle (current complaint).Approximately three weeks after the injection, on (b)(6) 2024, the patient received mmr vaccine (vaccine against measles, mumps, and rubella).2 weeks later, on (b)(6) 2024, the patient noted swelling.At this time hcp initiated patient on prednisone 40 mg, colchicine, and keflex daily.The day after, on (b)(6) 2024 she visited the emergency room due to swelling that caused difficulty breathing and received iv steroid.The patient noticed some improvement over the week after the treatment but on 09-jul-2024 the patient reported hard nodules and swelling.The swelling was more concentrated in areas where the filler was placed (unknown whether rha redensity or rha 4), and according to the hcp, some generalized swelling was present as well.Based on the information the relatedness of the difficulty to breath with the injection of teoxane products could not be excluded.Thus, the case was assessed as reportable to the fda.No further information could be retrieved at the time of this report.
Additional Manufacturer Narrative
The symptoms are monitored and additional information will be added to final report.
Additional Manufacturer Narrative
Delayed allergic reactions that may manifest as swelling and consequently difficulty breathing, as well as nodules and induration weeks to years after injection are well-known and documented reactions in the context of hyaluronic acid dermal filler injections.They are immune-mediated reactions that can be triggered by patient predisposition, trauma, vaccines (in this case patient received mmr vaccine), or infections.Adequate treatment usually leads to a good resolution of the symptoms, without sequelae.In addition, the risk of such reactions is mentioned in the instructions for use of our products.Of note, rha 4 is not indicated for cheeks in the us.
Event or Problem Description
Primevigilance notified teoxane of an adverse event on (b)(6) 2024.The patient was injected on (b)(6) 2024 with: 1 ml of rha redensity in the perioral lines.The injection was done with a 31g needle (complaint (b)(4)).1.2 ml of rha 4 in the cheekbone.The injection was done with a 27g needle (current complaint).Approximately three weeks after the injection, on (b)(6) 2024, the patient received mmr vaccine (vaccine against measles, mumps, and rubella).2 weeks later, on (b)(6) 2024, the patient noted swelling.At this time hcp initiated patient on prednisone 40 mg, colchicine, and keflex daily.The day after, on (b)(6) 2024 she visited the emergency room due to swelling that caused difficulty breathing and received iv steroid.The patient noticed some improvement over the week after the treatment but on (b)(6) 2024 the patient reported hard nodules and swelling.The swelling was more concentrated in areas where the filler was placed (unknown whether rha redensity or rha 4), and according to the hcp, some generalized swelling was present as well.Based on the information the relatedness of the difficulty to breath with the injection of teoxane products could not be excluded.Thus, the case was assessed as reportable to the fda.Despite reminders, no additional information could be received.Thus, the complaint was closed as is.

• Brand Name: RHA 4
• Common Device Name: HYALURONIC ACID DERMAL FILLER
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: izabela bat ; SZ
• MDR Report Key: 19947301
• Report Number: 3005975625-2024-00456
• Device Sequence Number: 17982176
• Product Code: LMH
• UDI-Device Identifier: 07640173232704
• UDI-Public: 7640173232704
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2024
• Device Lot Number: 22482JL0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female