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

Model Number NOT APPLICABLE

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hematoma (1884); Paralysis (1997)

Event Date 11/04/2021

Event Type  Injury  

Event Description

According to the information received on 05 nov 2021, a patient was injected on (b)(6)2021 in the temples area with a teosyal rha 4 ((b)(4)) product and in the cheeks with a teosyal redensity 1 (batch number unknown - see complaint (b)(4)) product.Immedialtely after the injection of the teosyal rha 4, the patient complained a hematoma on the right temporal area.The hematoma has been immediately managed by area compression and ice application during 3 days.Furthermore, a week after, the patient noticed that she badly closed her right eye and her mouth did not open on the right side.A hemiparesis due to the hematoma was suspected.Two medical experts of the affiliate ((b)(6)) were contacted in order to help in the management of this case.In their opinion, the problem was due to a facial nerve paralysis induced by the hematoma.However, according to the injector, the moderate hematoma was localized and did not descend into the distal area of the face so did not compromise the mandibular branches of the facial nerve.The problem seemed to be a bell¿s paralysis due to excessive use of ice and was confirmed by a neurologist.On the medical experts opinion, the problem will solve even if it could take time.On (b)(6) 2021, the hematoma was completely reabsorbed and the paralysis was slowly regressing.According to the latest information received on 30 nov 2021, the situation is getting better.

Manufacturer Narrative

Additional mfr narrative: batch number of the related product has been retrieved and quality investigations performed.The batch has been released in accordance with the manufacturers' specifications.No other complaint has been registered for this batch number to date.Corrected data: two local medical experts have been contacted to manage the situation.A neurologist also confirmed the bell¿s paralysis.According to the received investigation, this case seems related to a bell¿s paralysis in the injected area.According to the injector, this problem was due to excessive use of ice on the hematoma.The problem has been confirmed also from a neurologist.Batch analyse undertaken confirms that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed.

• Brand Name: TEOSYAL RHA 4
• 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: 12922677
• MDR Text Key: 281654738
• Report Number: 3005975625-2021-00679
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P170002,
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-212426B0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Female