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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC HYLAN G-F 20 ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC HYLAN G-F 20 ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number 00089149-02
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Muscle Spasm(s) (1966); Rash (2033); Twitching (2172); Cramp(s) (2193); Numbness (2415); Blood Loss (2597); Convulsion/Seizure (4406)
Event Date 05/12/2001
Event Type  Injury  
Event Description
In 10 second after 2nd year 2nd injection muscle cramps and twitching in right calf of right knee of injection 10 minutes of bleedings (b)(6) 2001 hospitalization. Still 5 months later full body cramping and spasms, loss of some body function numbness in both legs. Neuro check and ¿wm spams¿ body contractions. Conscious/seizure like movement. At this time hospitalization twice. Dr. Made note of rash on right hip of right leg of right knee of injection in (b)(6) and (b)(6) 2001. Rash and bruises amd min¿s spasms, convulsions.
 
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Brand NameSYNVISC HYLAN G-F 20
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10816314
MDR Text Key216175422
Report NumberMW5097746
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse Practitioner
Type of Report Initial
Report Date 11/01/2001
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date01/11/2002
Device Model Number00089149-02
Device Catalogue Number8008US-01
Device Lot Number0008914901 L0022
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

Patient Treatment Data
Date Received: 11/09/2020 Patient Sequence Number: 1
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