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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC ONE INJ 8MG/ML ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Off-Label Use (1494)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/31/2019
Event Type  Injury  
Event Description
(b)(6), ref coordinator from mdo called in new rx for synvisc one and confirmed off label use into shoulder. Md approved off label use.
 
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Brand NameSYNVISC ONE INJ 8MG/ML
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key9552603
MDR Text Key173945895
Report NumberMW5092030
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier58468009003
UDI-Public58468009003
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 12/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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