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

Model Number NOT APPLICABLE

Device Problem Unintended Ejection (1234)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

Event Type  malfunction  

Manufacturer Narrative

Needle ejections are well known and described technical issues following dermal filler injections.They are usually due to a wrong screwing of the needle into the luer lock, leading to pressure issues at the luer lock and ultimately, the ejection of the needle.In a vast majority of times, those are inconsequential, however an ejection in the eye area, for example, can lead to serious injuries.Good assembly practices are provided with the instructions for use of the product.Additionally, in this case the product has been retrieved and we tried to reproduce the issue, however the reported issue could not be confirmed.The batch has been released in accordance with the specifications.No non-conformity was opened through productions.

Event Description

The reported event happened outside of the u.S., in (b)(6).According to the received information, on the day of the use of teosyal rha3, the practitioner experienced a needle ejection with the needles provided with the package.No patient consequence was reported.

• Brand Name: TEOSYAL RHA 3
• Type of Device: HYALURONIC ACID DERMAL FILLER GEL
• Manufacturer (Section D): TEOXANE SA; rue de lyon, 105; geneva, CH-12 03; SZ CH-1203
• Manufacturer (Section G): SAME AS CONTACT OFFICE; same as contact office
• Manufacturer Contact: nicolas caill ; rue de lyon, 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 9829691
• MDR Text Key: 202694402
• Report Number: 3005975625-2020-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P170002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TP27L-182824A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• 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