• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDICIS PHARMACEUTICAL CORP. / GALDERMA LABORATORIES, L. P. RESTYLANE LYFT IMPLANT, DERMAL FOR AESTHETIC USE Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTYLANE LYFT
Type of DeviceIMPLANT, DERMAL FOR AESTHETIC USE
Manufacturer (Section D)
MEDICIS PHARMACEUTICAL CORP. / GALDERMA LABORATORIES, L. P.
MDR Report Key8164961
MDR Text Key130617338
Report NumberMW5082151
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/13/2018
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

-
-