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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE PFS ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC ONE PFS ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Shipping Damage or Problem (1570)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Event Description
Per clarification response from md office, the patient has quantity of one syringe for the synvisc one injection for a onetime dose injected into the hip for hip pain. Medication has not shipped from (b)(6). No further information provided. Reported to (b)(6) by: health professional.
 
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Brand NameSYNVISC ONE PFS
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key11055743
MDR Text Key223455559
Report NumberMW5098480
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 Other Health Care Professional
Type of Report Initial
Report Date 12/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2020
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
Is This a Reprocessed and Reused Single-Use Device?

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