FDA Adverse Event Injury Summary report: N

SYNVISC ONE

MDR report key: 4916365 · Received July 9, 2015

Report

Report Number
MW5044176
Event Type
Injury
Date Received
July 9, 2015
Date of Event
July 7, 2015
Report Date
July 8, 2015
Manufacturer
GENZYME
Product Code
MOZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MI, US
Reporter Occupation
PHARMACIST

Narratives

Description of Event or Problem · 1

PT DOES NOT WANT SYNVISC ONE FILLED BECAUSE INSURANCE WON'T COVER AND HE FELT MEDICATION WAS INEFFECTIVE THE LAST TIME HE RECEIVED IT. AMOUNT: 48 MG; FREQUENCY: "G6#" MONTHS; ROUTE: INTRA-ARTICULARLY. DATE OF USED: 06/2015 TO UNKNOWN. REASON FOR USE: OSTEOARTHRITIS OF THE KNEE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
444822 SYNVISC ONE SYNVISC ONE, 48 MG/6 ML MOZ GENZYME

Patients

Seq Age Sex Outcome Treatment
1 59 YR Other NOT PROVIDED