FDA Adverse Event Summary report: N

SYNVISC ONE (HYLAN G-F 20) INJECTION

MDR report key: 1834089 · Received September 2, 2010

Report

Report Number
2246315-2010-00173
Date Received
September 2, 2010
Report Date
August 27, 2010
Manufacturer
GENZYME BIOSURGERY (RIDGEFIELD)
Product Code
MOZ
PMA / PMN Number
P940015
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

INCREASING PAIN [PAIN]. INCREASING EFFUSION [EFFUSION]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 27-AUG-2010 FROM A COMPANY REPRESENTATIVE, REGARDING A (B)(6), FEMALE, PATIENT. THE PATIENT HAD HISTORY OF A KNEE VIDEO ARTHROSCOPY IN MARCH 2010. THE PATIENT EXPERIENCED INCREASING PAIN AND EFFUSION AFTER RECEIVING SYNVISC-ONE. THE PATIENT RECEIVED SYNVISC-ONE AT THE END OF MAY 2010 ON AN UNSPECIFIED DATE IN AN UNSPECIFIED LOCATION. THE HCP REPORTED IN THE COURSE OF THREE WEEKS THE PATIENT EXPERIENCED "INCREASING PAIN AND EFFUSION, PUNCTURE 25 ML". THERE WAS "NO EXAMINATION". THE PAIN WAS "BEARABLE AFTER AND SPORTY ACTIVITIES WERE POSSIBLE". ON AN UNSPECIFIED DATE IN AUGUST 2010, THE PATIENT PRESENTED AT THE (B)(6). THERE WAS NO PATHOLOGICAL FINDING, NO ADVERSE REACTION CAUSED BY THE INJECTION AND THE PATIENT WAS ADVISED TO REDUCE PHYSICAL ACTIVITY. DURING THE PATIENT'S PRESENTATION WITH A (B)(6) ORTHOPEDIST, THE PATIENT REPORTED SHE HAD NO INFLAMMATION AND WAS GOING TO RECEIVE THERAPY WITH ACUPUNCTURE. THE PATIENT'S MEDICATION INCLUDED ORAL MEDICATION WITH WOBENZYM AND KYTTA OINTMENT. THE PATIENT HAD A VISIT PLANNED FOR OCTOBER 2010 AT THE (B)(6). AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN. MANUFACTURER'S COMMENT: NO FURTHER DETAILS WERE RECEIVED. FURTHER INFORMATION HAS BEEN REQUESTED.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 63 YR Other