MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 3; HYALURONIC ACID DERMALL FILLER GEL

Model Number NOT APPLICABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Angioedema (4536)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

Localized allergic reactions that occur through immediate oedema are well-known and documented reactions in hyaluronic acid injections.With 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, on 1st of september the patient was injected with a rha 3 product in the upper lip.On a unknown date the patient experienced an angioedema on the upper lip.On 2nd of september, she was treated with hyaluronidase.Despite several reminders, no further information could have been obtained regarding the evolution of the symptoms.

• Brand Name: TEOSYAL RHA 3
• Type of Device: HYALURONIC ACID DERMALL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon 105; gevena, CH120 3; SZ CH1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE; same as contact office
• Manufacturer Contact: fiona di folco ; rue de lyon 105; geneva, CH120-3 ; SZ CH1203
• MDR Report Key: 12546258
• MDR Text Key: 273993103
• Report Number: 3005975625-2021-00515
• Device Sequence Number: 1
• Product Code: LMH
• UDI-Device Identifier: 07640173230038
• UDI-Public: 07640173230038
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP27L-203414A
• Date Manufacturer Received: 09/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2020
• 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