MAUDE Adverse Event Report: TEOXANE SA RHA 3; HYALURONIC ACID DERMAL FILLER GE

Lot Number	TP27L-22421JLO
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vascular complications are rare and serious side effects, although they are widely known and documented in the context of dermal filler injections.They are related to the accidental injection of the product inside a blood vessel, leading to its occlusion.The local deprivation of blood supply causes tissue anoxia.If enough hyaluronidase is injected on time, symptoms can be fully resolved without sequalae.If the vascular complication is not detected, diagnosed, and treated promptly, it can lead to skin necrosis.The risk of such adverse reactions is mentioned in the instructions for use of teosyal products.
Event or Problem Description
On august 30, 2023, the spanish subsidiary notified us of an adverse event following the use of teosyal puresense rha 3 in a patient.According to the information received, a patient was injected on (b)(6) 2023, with 0.8 ml of teosyal puresense rha 3 in the lips (0.4 ml in the upper lip, and 0.3 ml in the lower lip) and 0.1 ml in the piriform fossa (nasolabial folds).The injection was performed with a needle using the retrotracing technique.Immediately after the injection, the practitioner noticed a vascular compromise, as the patient presented with whitening and delayed capillary refill on the upper right lip, nose (nasal ala, dorsum, and radix), and glabella.One of our local medical advisors was contacted and 3000 iu of hyaluronidase were administered on the same day, along with the following treatment: nonsteroidal anti-inflammatory drug: aspirin, 300 mg.Corticosteroids: urbason, 40 mg.One day later, on (b)(6) 2023, the capillary refill improved.During physical examination, erosion in the in the right nasal introit was detected.Another 1500 iu of hyaluronidase were prescribed, along with the following treatment: antibiotics: mupirocin, ciprofloxacin, gastric protector: omeprazol, hydrating cream: ciscaplast, and nasal reparing cream.Finally, on september 21, 2023, we were informed that the patient had fully recovered, without any further complications.Thus, this case was considered closed.

• Brand Name: RHA 3
• Common Device Name: HYALURONIC ACID DERMAL FILLER GE
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer (Section G): TEOXANE SA; rue de lyon 105; geneva, 1203 ; SZ 1203
• Manufacturer Contact: inés moreno pons ; rue de lyon 105; geneva, 1203 ; SZ 1203
• MDR Report Key: 17815695
• Report Number: 3005975625-2023-00634
• Device Sequence Number: 2302047
• Product Code: LMH
• UDI-Device Identifier: 07640173230045
• UDI-Public: 07640173230045
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P170002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/26/2023

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: 10/31/2024
• Device Lot Number: TP27L-22421JLO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2022
• 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 Age: 31 YR
• Patient Sex: Male