SYNVISC (HYLAN G-F 20) INJECTION

Report

Report Number: 2246315-2012-00344
Event Type: Injury
Date Received: November 6, 2012
Date of Event: January 1, 2011
Report Date: October 15, 2012
Manufacturer: GENZYME BIOSURGERY (RIDGEFIELD)
Product Code: MOZ
PMA / PMN Number: PMA P940015
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF THE PRODUCT IS NOT AFFECTED BY THIS REPORT.

Description of Event or Problem · 1

ANAPHYLACTIC TYPE REACTION. CASE DESCRIPTION: SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2012 FROM A PHYSICIAN REGARDING A PATIENT (DEMOGRAPHICS NOT PROVIDED), INITIALS UNKNOWN. THE PATIENT'S MEDICAL HISTORY WAS NOT PROVIDED. ON AN UNSPECIFIED DATE IN 2011 (ONE AND A HALF YEARS AGO), THE PATIENT INITIATED TREATMENT WITH SYNVISC (HYLAN G-F 20) INJECTION, AT A DOSE OF 2 ML (ROUTE OF ADMINISTRATION AND FREQUENCY NOT PROVIDED). THE LOT NUMBER FOR SYNVISC WAS NOT PROVIDED. THE PATIENT RECEIVED A TOTAL OF THREE INJECTIONS. ON AN UNSPECIFIED DATE, THAT THE PATIENT DEVELOPED ANAPHYLACTIC TYPE REACTION SHORTLY AFTER RECEIVING SYNVISC INJECTION. THE PHYSICIAN REPORTED THAT THE PATIENT HAD ALMOST DIED BUT WAS ABLE TO MANAGE AS THE PATIENT WAS STILL IN THE WAITING ROOM AT THE OFFICE. THE PHYSICIAN ASSESSED THE EVENT AS SERIOUS DUE TO LIFE THREATENING. ON AN UNSPECIFIED DATE, THE PATIENT RECOVERED FROM THE EVENT OF ANAPHYLACTIC TYPE REACTION. CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE INTENSITY OF THE EVENT WAS NOT PROVIDED. THE REPORTING PHYSICIAN ASSESSED THE CASUAL RELATIONSHIP BETWEEN SYNVISC AND THE EVENT AS POSSIBLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNVISC (HYLAN G-F 20) INJECTION	INTRA-ARTICULAR HYALURONIC ACID	MOZ	GENZYME BIOSURGERY (RIDGEFIELD)	UNK	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Life Threatening