MAUDE Adverse Event Report: MEDICIS PHARMACEUTICAL CORP. / GALDERMA LABORATORIES, L. P. RESTYLANE LYFT IMPLANT, DERMAL FOR AESTHETIC USE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2018

Event Type  malfunction  

Event Description

Medicis restylane lyft hyaluronic acid injection syringes have a manufactured defect that allows the needle to pop off during injections. While i have not injured a pt because of this, the needle acts as a projectile and could puncture an eyeball. I have had this needle pop off at least 6 times. The fda needs to address this before someone is blinded.

• Brand Name: RESTYLANE LYFT
• Type of Device: IMPLANT, DERMAL FOR AESTHETIC USE
• Manufacturer (Section D): MEDICIS PHARMACEUTICAL CORP. / GALDERMA LABORATORIES, L. P.
• MDR Report Key: 8164961
• MDR Text Key: 130617338
• Report Number: MW5082151
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/12/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage