RESTYLANE INJECTABLE GEL

MDR report key: 798614 · Received December 22, 2006

Report

Report Number: 9710154-2006-00013
Event Type: Other
Date Received: December 22, 2006
Date of Event: December 7, 2006
Report Date: December 20, 2006
Manufacturer: Q-MED AB
Product Code: LNM
PMA / PMN Number: p020023
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TELANGIECTASIA IS NOT DESCRIBED IN THE DEVICE'S LABELING. ADDITIONAL PMA# P040024.

Description of Event or Problem · 1

THIS SPONTANEOUS REPORT OF A NON-SERIOUS UNLABELED EVENT (TELANGIECTASIA) IS BEING SUBMITTED AS A 10-DAY REPORT. A HEALTH CARE PROVIDER REPORTED THAT AN ADULT FEMALE PT UNDERWENT INJECTIONS OF RESTYLANE IN2006 INTO THE NASOLABIAL FOLDS AND MIDDLE OF THE CHIN. BETACAINE WAS USED FOR ANESTHESIA PRE-PROCEDURE. NO ADD'L PROCEDURES WERE PERFORMED. THE PT HAS NO KNOWN ALLERGIES. PAST THERAPIES INCLUDE RESTYLANE INJECTIONS EVERY SIX MONTHS FOR OVER A YEAR WITH "NORMAL BRUISING." IMMEDIATELY POST-IMPLANT, THE PT DEVELOPED REDNESS (INJECTION SITE ERYTHEMA). THAT SAME EVENING, SHE DEVELOPED SORENESS (INJECTION SITE PAIN). SHE ALSO DEVELOPED TELANGIECTASIA (TELANGIECTASIA), DESCRIBED AS MINUTE RED BLOOD VESSELS, ALONG WITH SMALL, WHITE LUMPS WITHIN THE NASOLABIAL AREA, WHICH ARE OBSERVABLE WHEN THE FOLDS ARE SPREAD APART (EXTRUSION OF DEVICE). AS OF THE DATE THIS REPORT WAS RECEIVED, THE EVENTS PERSISTED. THE LOT NUMBER AND EXPIRATION DATE WERE NOT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTYLANE INJECTABLE GEL	INJECTABLE DERMAL FILLER	LNM	Q-MED AB	NI	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	*			UNSPECIFIED BLOOD PRESSURE MEDICATION