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

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Angioedema (4536)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

According to the information received, this case seems to be an angioedema which is a well-known and documented adverse effect of dermal fillers. Additionally, the risk of such adverse event is also mentioned in the instructions for use of our products. Batch analyses undertaken confirms that the products passed sterility and quality compliance tests, therefore the imputability of the product seems dismissed.

Event Description

According to the received information, the patient was injected on (b)(6) 2021 with teosyal rha 2 in the lips (rc/2109083). She was also injected on (b)(6) 2021 with teosyal puresense ultra deep in the zygomatic malars (rc/2109084) and teosyal rha 4 in the zygomatic malars and soof (rc/2109085). Starting on (b)(6) 2021, the patient developed severe edema, induration, redness, with sensation of heat, appearing at all injection sites. She then developed an angioedema. Initial treatments included a regimen of oral corticosteroids, antihistamines and antibiotic therapy. Afterwards, redness of the chin area decreased but the edema and induration persisted both in the chin and in the other injected areas. The diagnosis of angioedema was confirmed on (b)(6) 2021, which updated the reportability of this case. On 04 october 2021, we received confirmation about the complete resolution of the adverse event.

• 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: 12727471
• MDR Text Key: 279273257
• Report Number: 3005975625-2021-00560
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: ES
• 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: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-205021A0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/01/2021 Patient Sequence Number: 1