RESTYLANE INJECTABLE GEL

MDR report key: 1379787 · Received May 12, 2009

Report

Report Number: 2032896-2009-00009
Event Type: Other
Date Received: May 12, 2009
Date of Event: January 1, 2009
Report Date: May 11, 2009
Manufacturer: Q-MED AB
Product Code: LMH
PMA / PMN Number: P040024
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

ADD'L 510(K): P020023.

Description of Event or Problem · 1

ON (B) (6) 2009, A SPONTANEOUS REPORT WAS RECEIVED FROM A FEMALE PT, WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER) ON (B) (6) 2009, TO THE NASOLABIAL FOLDS. MEDICAL HISTORY INCLUDED PREVIOUS RESTYLANE INJECTIONS TO THE NASOLABIAL FOLDS FOR THE PAST 3 YEARS WITH NO PROBLEMS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON AN UNSPECIFIED DATE IN (B) (6) 2009, FOLLOWING IMPLANTATION, THE PT EXPERIENCED SEVERE BRUISING, SCARRING, CONTINUED REDNESS, AND PROFOUND MARKS. ON (B) (6) 2009, THE PT REPORTED BEING UNCOMFORTABLE FOR THE PAST 5 MONTHS DUE TO THE EVENTS. THE EVENTS WERE SLOWLY DISSIPATING AND THE INJECTION SITE WAS STILL HEALING. THE LOT NUMBER AND EXP DATE WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			NOT REPORTED