FDA Adverse Event Injury Summary report: N

SYNVISC

MDR report key: 2071856 · Received April 22, 2011

Report

Report Number
MW5020388
Event Type
Injury
Date Received
April 22, 2011
Date of Event
April 22, 2011
Report Date
April 22, 2011
Product Code
MOZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NY, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS INJECTED WITH THE TRIPLE DOSE OF SYNVISC IN MY RIGHT KNEE(B)(6) 2011. I HAD ARTHROSCOPIC KNEE SURGERY AND AS A RESULT THE OUTCOME WAS I NEED FULL KNEE REPLACEMENT. TO ALLEVIATE THE PAIN I HAD THIS INJECTION, WHICH REALLY HURT. SINCE THEN I HAVE EXPERIENCED EVERY ONE OF THE ADVERSE REACTIONS AS LISTED. DIFFICULTY BREATHING, HEADACHE, NAUSEA, CONSTIPATION, STOMACH ACHES, LEG CRAMPING (NOT THE RIGHT KNEE), JOINT DISCOMFORT, RASH AND ITCHINESS ON ARMS, SHOULDER JOINT HURTS, UPSET STOMACH, GAS PAIN (SUPPOSITORY HELPED). LOWER BACK PAIN. I CALLED THE KNEE SURGEON AND SHE THOUGHT I SHOULD SEE MY PRIMARY CARE PHYSICIAN, SHE THOUGHT I HAD A URINARY TRACT INFECTION. I DO NOT HAVE ONE. THESE SYMPTOMS OCCURRED 2 DAYS AFTER THE INJECTION. I DO NOT KNOW IF THE ULTIMATE RESULTS WOULD BENEFIT ALL THIS DISCOMFORT. THE PAIN IN MY RIGHT KNEE IS DIFFERENT NOW.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SYNVISC INJECTION MOZ

Patients

Seq Age Sex Outcome Treatment
1 68 YR