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

Model Number NOT APPLICABLE

Device Problem Insufficient Information (3190)

Patient Problems Skin Infection (4544); Subcutaneous Nodule (4548)

Event Date 09/30/2021

Event Type  Injury  

Manufacturer Narrative

Additional mfr narrative: batch data review : quality controls of the related product's batch records have been performed.The product is compliant with specifications.No defect has been highlighted during production.Batch history : another complaint was registered to date for this batch number : rc/2105130, for a needle ejection, unrelated to the present complaint.Corrected data: the injector requested medical assistance and was put in contact with a local medical expert.

Event Description

This case occured outside of the usa, in (b)(6).According to the information received on (b)(6) 2021, a patient was injected on (b)(6) 2021 with a teosyal rha 4 product (tpul-203022c0), 1.2ml, in the marionette lines.Six months later, on (b)(6) 2021, the patient complained about nodules of severe intensity in the injected areas, and was treated with corticoids (prednisolone during 7 days).The injector requested medical assistance and was put in contact with a local medical expert to discuss the management of this adverse event.On (b)(6) 2021, we were informed that the corticoids did not have any effect on the nodules and that a skin infection was suspected.On (b)(6) 2021, the injector reported that the event worsened despite 2 weeks treatment of high dose corticosteroids, and decided to inject the patient with hyaluronidase.Considering this information, we decided to update the reportability of this case.

• 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: 12786388
• MDR Text Key: 281680182
• Report Number: 3005975625-2021-00607
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170002,
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-203022C0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2020
• 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
• Patient Age: 54 YR
• Patient Sex: Female