FDA Adverse Event Other Summary report: N

RESTYLANE

MDR report key: 565719 · Received December 27, 2004

Report

Report Number
MW1034186
Event Type
Other
Date Received
December 27, 2004
Date of Event
October 15, 2004
Report Date
November 5, 2004
Manufacturer
MEDICIS AESTHETICS INC.
Product Code
LMH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report

Narratives

Description of Event or Problem · 1

PT RECEIVED AN INJECTION OF RESTYLANE INTO LIPS TO FILL IN SOME DEEP LINES. IMMEDIATELY AFTER THE INJECTION UPPERLIP AREA TURNED WHITE, THEN A PURPLEISH COLOR, THE NEXT DAY WHOLE UPPER LIP AREA ON THE RIGHT SIDE OF FACE BLISTERED. OVER THE NEXT WEEK THE CONDITION WORSENED AND BLISTERED. OVER THE NEXT WEEK THE CONDITION WORSENED AND BLISTERING OCCURRED ON THE INSIDE OF LIP. THERE WAS A TREMENDOUS AMOUNT OF PAIN INVOLVED WITH THE REACTION. DERMATOLOGIST WAS VERY CONCERNED ABOUT THE REACTION AND CONTACTED THE MEDICAL CO, MEDICIS AESTHETICS. PT ALSO CONSULTED A PLASTIC SURGEON ABOUT THE DAMAGED AREA. HE THINKS THE RESTYLANE CAUSED AN EMBOLISM AND BLOCKED THE BLOOD FLOW TO THE AREA AND CAUSED NECROSIS OF THE TISSUE. HE ALSO CONTACTED THE CO AT THAT TIME. HE CONSULTED WITH THE DERMATOLOGIST AND THEY BOTH AGREE THAT THERE IS MAJOR DAMAGE TO THE AREA AND THERE WILL BE SCARRING AFTER HEALING. THE CO DIDN'T RESPOND TO PT'S CALL UNTIL THEY CALLED BACK AND ASKED TO SPEAK TO A SUPERVISOR IN THE CUSTOMER RELATIONS DEPARTMENT. PT WAS TOLD THAT ALTHOUGH THEY UNDERSTOOD PROBLEM, THERE WAS NOTHING THAT THEY COULD DO. THEY HAVE BEEN TOTALLY PERPLEXED BY THE RESPONSE OF THE CO, BECAUSE PT DOES NOT WANT THIS TO HAPPEN TO ANYONE ELSE AND THEY DO NOT WANT ANYONE ELSE TO HAVE TO GO THROUGH THIS PAIN AND SUFFERING THAT THEY HAVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 RESTYLANE INJECTION LMH MEDICIS AESTHETICS INC. * *

Patients

Seq Age Sex Outcome Treatment
1 39 YR Other