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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SANOFI / GENZYME CORPORATION SYNVISC 1 ACID, HYALURONIC, INTRAARTICULAR

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SANOFI / GENZYME CORPORATION SYNVISC 1 ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Date 12/06/2021
Event Type  Injury  
Event Description
Within 24 hours of the synvisc i injection, on (b)(6) 2021, i was unable to independently walk, drive or navigate my home. I experienced extreme and significant swelling of the knee, debilitating pain and tremendous fear that the condition i wanted to correct was made far worse. Despite intensive icing, four days after the injection, i was prescribed prednisone, which i had no effect. Day six of the injection and after three days of prednisone (sunday), my husband took me to the emergency pain clinic operated by the orthopedic practice. I was examined, the dosage of prednisone increased, and i was fitted with a brace. Thursday, (b)(6) 2021, my treating physician, withdrew fluid from the knee along with synvisc for analysis and indicated i had an extremely rare reaction to the synvisc. Today, (b)(6) 2021, i still have great pain and simply seek a return to my pre-injection status, mild but tolerable knee discomfort. With synvisc i expected some discomfort - but no disability.
 
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Brand NameSYNVISC 1
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SANOFI / GENZYME CORPORATION
MDR Report Key13059906
MDR Text Key282640351
Report NumberMW5106202
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/20/2021 Patient Sequence Number: 1
Treatment
NSAID'S AS NEEDED
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