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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNVISC INTRA-ARTICULAR HYALYRONIC ACID

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SYNVISC INTRA-ARTICULAR HYALYRONIC ACID Back to Search Results
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.
 
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Brand NameSYNVISC
Type of DeviceINTRA-ARTICULAR HYALYRONIC ACID
MDR Report Key5398084
MDR Text Key37089502
Report NumberMW5059779
Device Sequence Number1
Product Code MOZ
Reporter Country CodeUS
Number of Events Reported1
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 Received01/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/23/2016 Patient Sequence Number: 1
Treatment
RX MEDS: PROPRANOLOL 10 MG, PRN FOR
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