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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORP. SYNVISC-ONE, 48 MG

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GENZYME CORP. SYNVISC-ONE, 48 MG Back to Search Results
Lot Number 5RSF004
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Missed Dose (2561)
Event Date 10/21/2018
Event Type  Injury  
Event Description
Pt reported 2 recent hospitalizations (b)(6) 2018 and (b)(6) 2018 for liver issues. (b)(6) has not sent synvisc one since (b)(6) 2016. Dose or amount: 48 mg; frequency: inject once; route: injection. Dates of use: (b)(6) 2016. Diagnosis or reason for use: osteoarthritis of knee.
 
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Brand NameSYNVISC-ONE, 48 MG
Type of DeviceSYNVISC-ONE, 48 MG
Manufacturer (Section D)
GENZYME CORP.
MDR Report Key8194387
MDR Text Key131593346
Report NumberMW5082533
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2018
Device Lot Number5RSF004
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

Patient Treatment Data
Date Received: 12/21/2018 Patient Sequence Number: 1
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