RESTYLANE INJECTABLE GEL

MDR report key: 1823790 · Received August 30, 2010

Report

Report Number: 2032896-2010-00028
Event Type: Other
Date Received: August 30, 2010
Date of Event: August 17, 2010
Report Date: August 21, 2010
Manufacturer: Q-MED AB
Product Code: LMH
PMA / PMN Number: P040024
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PMA/510K #: P020023.

Description of Event or Problem · 1

ON (B)(6) 2010, A SPONTANEOUS REPORT BY A PHYSICIAN WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A FEMALE (AGE NOT REPORTED) WHO RECEIVED AN INJECTION OF RESTYLANE (CROSS-LINKED HYALURONIC ACID DERMAL FILLER). MEDICAL HISTORY, SKIN TYPE AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT RECEIVED AN INJECTION OF RESTYLANE (AMOUNT INJECTED NOT REPORTED) ON (B)(6) 2010 TO AN UNSPECIFIED INJECTION SITE. PRE-PROCEDURE MEDICATION USED WAS NOT REPORTED. ADDITIONAL PROCEDURES PERFORMED AT THE TIME OF IMPLANTATION INCLUDED DYSPORT (ABOBOTULINUMTOXINA). ON (B)(6) 2010, THE NIGHT OF THE IMPLANTATION, THE PATIENT DEVELOPED TACHYCARDIA. THE PATIENT CALLED THE PHYSICIAN'S OFFICE THAT NIGHT AND REPORTED THE TACHYCARDIA. THE TACHYCARDIA LATER RESOLVED ON AN UNSPECIFIED DATE IN (B)(6) 2010. ON (B)(6) 2010, THE PATIENT CALLED THE PHYSICIAN AGAIN AND REPORTED A RECURRENCE OF TACHYCARDIA AND THE DEVELOPMENT OF SHORTNESS OF BREATH AND NAUSEA. THE PHYSICIAN'S OPINION OF CAUSALITY WAS NOT REPORTED. THE PHYSICIAN'S ASSESSMENT OF SEVERITY OF THE EVENTS WAS NOT REPORTED. DESPITE FOLLOW-UP ATTEMPTS, NO RESPONSE WAS RECEIVED FROM THE PHYSICIAN.

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			Other	CON MEDS = UNK\| PREV MEDS = UNK