FDA Adverse Event Injury Summary report: N

SYNVISC ONE HYLAN 6ML G-F20

MDR report key: 2823076 · Received October 30, 2012

Report

Report Number
MW5027491
Event Type
Injury
Date Received
October 30, 2012
Date of Event
October 23, 2012
Report Date
October 30, 2012
Manufacturer
GENZYME CORP
Product Code
MOZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
ME, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD SYNVISC INJECTED INTO MY SHOULDER ABOUT A WEEK AGO AND HAVE FELT LIKE I HAVE THE FLU EVER SINCE. I BECAME VERY NAUSEATED THAT NIGHT AND EXTREME CHILLS. I WOKE UP WITH A SINUS LIKE INFECTION, COLD THAT SEEMS LIKE A FLU AS I JUST FEEL LOUSY AND TODAY ABOUT A WEEK LATER, MY KNEES ACHE AND THEY RARELY DO. I HAD A FLU SHOT EXACTLY A MONTH PRIOR AND THE NURSE THEN COMMENTED THAT I SEEM TO HAVE A VERY SLIGHTLY ELEVATED TEMP 99.3, SO PERHAPS SHOULD WAIT FOR IT, BUT THE DR GAVE IT FLU SHOT ANYWAY. I DID NOT FEEL SICK UNTIL THE NIGHT OF THE SYNVISC SHOT, SO I AM NOT SURE IF I WAS ALREADY FIGHTING SOMETHING OFF, IF THE TWO SHOTS WERE TOO CLOSE TOGETHER OR IF I WOULD HAVE REACTED ANYWAY. I HAD NOTICED AROUND THE TIME OF THE FLU SHOT I ALSO HAVE A SMALL LYMPH NODE NOTICEABLE BEHIND MY LEFT EAR. I ALSO HAVE THYROID DISEASE AND MY DR JUST INCREASED MY THYROID MEDICINE LAST MONTH AS WELL FROM 25 MCG LEVOTHYROXINE TO 50. THE ONLY OTHER THING I CAN THINK OF IS THAT I HAVE GILBERT'S SYNDROME AS WELL SO PERHAPS METABOLIZING THE SHOTS IS CHALLENGED A BIT. FLU SHOT GIVEN EXACTLY A MONTH PRIOR AND THYROID LEVOTHYROXINE RECENTLY INCREASED. ALSO TAKING CELEBREX 2X DAY CAPSULES -100 PER-, WELLBUTRIN 75M SIMVASTATIN 10M, DESIPRAMINE 6M - I THINK ALL ARE MCG?... RECENTLY WITHIN 2 WKS WEANED OFF FROM 2 WK TRIAL OF LYRICA WHICH DID NOT HELP PAIN AT ALL AND HAD STRONG WITHDRAWL SYNDROME, EXTREME NAUSEA FOR ALMOST 2 WEEKS STRAIGHT. HAD A CORTIZONE SHOT 2 AND 1/2 MOS AGO AT DR'S OFFICE; ALREADY CHECKED AND NOT SUPPLIED BY THE MFR LINKED TO RECENT FUNGAL MENINGITIS CASES - THANK GOD!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNVISC ONE HYLAN 6ML G-F20 SYNVISC MOZ GENZYME CORP Y1114

Patients

Seq Age Sex Outcome Treatment
1 52 YR