RESTYLANE INJECTABLE GEL

MDR report key: 1994426 · Received February 3, 2011

Report

Report Number: 2032896-2011-00002
Event Type: Other
Date Received: February 3, 2011
Date of Event: January 1, 2011
Report Date: February 2, 2011
Manufacturer: Q-MED AB
Product Code: LMH
PMA / PMN Number: P020023
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

P040024.

Description of Event or Problem · 1

ON (B)(6) 2011, A SPONTANEOUS REPORT BY A REGISTERED NURSE (RN) WAS RECEIVED FROM A COMPANY REP REGARDING A (B)(6) OLD FEMALE WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY INCLUDED AN INJECTION OF DYSPORT (ABOBOTULINUMTOXINA) 50 UNITS TO THE GLABELLAR AREA ON (B)(6) 2010. THE PT'S SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2011, THE PT RECEIVED A 0.025 ML INJECTION OR RESTYLANE TO THE GLABELLAR LINES. IT WAS NOT REPORTED IF THE PT RECEIVED ANY PRE-PROCEDURE MEDICATIONS OR IF ANY ADD'L PROCEDURES WERE PERFORMED AT THE TIME OF IMPLANTATION. ON AN UNSPECIFIED DATE (B)(6) 2011, AFTER THE IMPLANTATION, THE PT DEVELOPED EYELID PTOSIS. THE PT PRESENTED TO THE CLINIC ON (B)(6) 2011 WITH EYELID PTOSIS. THE PHYSICIAN PRESCRIBED IODIPINE 1% 2-3 DROPS 3 TIMES DAILY FOR 4 WEEKS. THE RN DID NOT COMMENT ON THE CAUSALITY OR SEVERITY OF THE REPORTED EVENTS. THE LOT NUMBER AND EXP DATE WERE NOT REPORTED. ATTEMPTS TO OBTAIN ADD'L INFO ARE ONGOING.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR			CON MEDS=UNK