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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC INJ 8MG/ML(3X2ML)* ACID, HYALURONIC, INTRAARTICULAR

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GENZYME CORPORATION SYNVISC INJ 8MG/ML(3X2ML)* ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Missed Dose (2561)
Event Date 03/11/2020
Event Type  Injury  
Event Description
Spoke with patient. He stated that he never received week 4 dose that was shipped to mdo on (b)(6) due to mdo being closed. He is 2 weeks late on his 2nd dose. Missed dose consult done and advised patient that label will be for maintenance dose due to 2nd dose week 4 had been shipped to mdo. Dates of use: (b)(6) 2020 - present. Ae record id: (b)(4).
 
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Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
GENZYME CORPORATION
MDR Report Key9983077
MDR Text Key188890476
Report NumberMW5094209
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 Unknown
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
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

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