MAUDE Adverse Event Report: TEOXANE SA; DERMAL FILLER

Lot Number TPRL-210921C2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Vascular Problem (4441)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

Additional mfr narrative: batch data review: the batch data review was compliant with the applicable specifications.No element allows us to identify a defect in either the quality or the safety of the teosyal rha 1 product.Batch data history: one other complaint was registered to date (april 22, 2022) with this batch number: (b)(4) from (b)(6), linked to an adverse event (injection site mass).This complaint is unrelated to the current complaint.Corrected data: on april 05, 2022, a local medical expert was put in contact with the practitioner to advise on this case.Therefore, the corrective action including hyaluronidase injection and topical antibiotic therapy was implemented following the recommendation of the (b)(6) medical expert.

Event Description

This incident occurred outside of the usa, in (b)(6).According to information received as of (b)(6), 2022, a patient was injected on (b)(6), 2022, with 0.2 ml of rha redensity (tprl-210921c2) into the forehead depression and lines.One-day post-injection on (b)(6), 2022, the patient presented with redness and reticulate erythema, accompanied by mild skin blanching at the injection site.Following this event, on (b)(6), 2022, a local medical expert was put in contact with the practitioner, who recommended hyaluronidase injection, accompanied by a topical antibiotic (mupirocin; ointment) and acid acetylsalicylic (asa) for seven days.Therefore, on (b)(6), 2022, the patient received 2 cycles of hyaluronidase (500 iu).On (b)(6), 2022, as the capillary refill on the affected area was not improving well, the patient received 2 additional doses of hyaluronidase injection.On (b)(6), 2022, the capillary refill began to improve.The medical expert suggested continuing the topical antibiotic and asa for up to seven days.Eventually, on april 11, 2022, we were informed that on (b)(6), 2022 the patient again received another dose of hyaluronidase.Therefore, the symptoms began to subside properly, and the patient was recovering well.

• Brand Name: NA
• 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: 14192790
• MDR Text Key: 289964889
• Report Number: 3005975625-2022-00197
• 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: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Lot Number: TPRL-210921C2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female