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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
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Diarrhea (1811); Dyspnea (1816); Itching Sensation (1943); Rash (2033); Swelling (2091); Urinary Retention (2119)
Event Date 10/27/2000
Event Type  Injury  
Event Description
Giving injection in left knee of synvisc (b)(6) 2000 and the following day (b)(6) 2000 truncal itching, rash all the way to head. On (b)(6) 2000 lips swollen twice their size and patient was hospitalized. Urinary retention, expulsive diarrhea, swollen face, tachypneic, trouble breathing, sore throat, eyes swollen shut, transferred to our hospital on (b)(6) for continued steroid tx required epinephrine 1:1000; solumedrol; benadryl; inhalation racepinephrine. (b)(4).
 
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Brand NameSYNVISC HYLAN G-F 20
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key10811206
MDR Text Key215618291
Report NumberMW5097719
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/06/2000
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/06/2020 Patient Sequence Number: 1
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