MAUDE Adverse Event Report: SYNVISC; INTRA-ARTICULAR HYALYRONIC ACID

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Edema (1820); Feeding Problem (1850); Pain (1994); Tachycardia (2095); Hot Flashes/Flushes (2153); Chills (2191); Malaise (2359)

Event Date 02/05/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, i received a synvisc one injection in my left knee.Within hours the knee became edematous and very painful.Within 48 hours i developed flu like symptoms including generalized aches and pains, chills, hot flashes.My symptoms continued to worsen.I developed lower back pain, malaise, reduced appetite and tachycardia.I went to the emergency department on (b)(6), where i was treated with hydrocodone, solumedrol injection, oral prednisolone.On (b)(6), i received a cortisone injection from my orthopedic surgeon.The problem resolved after a few weeks.Treatment-hydrocodone, solumedrol injection, prescription for prednisolone on (b)(6), i received a cortisone injection from my orthopedic surgeon.The problem resolved after a few weeks.Treatment-hydrocodone, solumedrol injection, prescription for prednisolone.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALYRONIC ACID
• MDR Report Key: 5398084
• MDR Text Key: 37089502
• Report Number: MW5059779
• Device Sequence Number: 1
• Product Code: MOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: RX MEDS: PROPRANOLOL 10 MG, PRN FOR
• Patient Outcome(s): Disability
• Patient Age: 58 YR
• Patient Weight: 64