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

Model Number NOT APPLICABLE

Device Problem Unintended Ejection (1234)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Needle ejections are well known and described technical issues following the use of dermal fillers.They are usually due a wrong screwing of the needle into the luer lock leading to pressure issues at the luer lock.In a vast majority of cases, those issue are without any patient consequence, but an unintended ejection into the eye of a patient during a procedure can lead to serious injuries.Good assembly practices are available in the instruction for use of the products.

Event Description

This event happened outside of the u.S., in (b)(6).According to the received information, when using a teosyal rha 4 syringe, a needle ejection was reported.No patient consequences observed.This case is reported due to possible serious injury in case of recurrence.

• Brand Name: TEOSYAL RHA 4
• 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: stephanie antunes ; rue de lyon 105; geneva, CH-12-03 ; SZ CH-1203
• MDR Report Key: 9283503
• MDR Text Key: 191919580
• Report Number: 3005975625-2019-00028
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: NOT APPLICABLE
• Device Lot Number: TPUL-190325C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other