• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number ARSP006C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Was in the emergency room twice over the weekend to drain fluid from her knees (right knee) [effusion (r) knee]. Has been in the er because of pain a swelling (right knee) [aching (r) knee]. Has been in the er because of pain a swelling [swelling of r knee]. Case narrative: initial information received on 07-sep-2021 from united states regarding an unsolicited valid serious case received from a patient. This case involves a (b)(6) female patient who experienced was in the emergency room twice over the weekend to drain fluid from her knees (right knee), has been in the er because of pain a swelling (right knee) with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection dosage unknown every week (times 3 weeks with a week in bet) in right knee (lot - unk) for osteoarthritis in knee. The information regarding lot number was requested. On an unknown date, after unknown latency, the patient had been in the er because of pain a swelling (right knee) (arthralgia, joint swelling). On an unknown date in 2021, during the weekend, the patient was in the emergency room twice over the weekend to drain fluid from her knees (right knee) (joint effusion; seriousness criteria: intervention required). The patient had been in touch with her hcp (healthcare professional) over the long weekend, was given some anti-inflammatory medications; however it had been a week since her injection and she was severely hoppled by the event. Relevant laboratory test results included: aspiration joint - in 2021: [drain fluid from her knees]. Corrective treatment: drain fluid from her knees for event knee effusion; anti-inflammatory medications for rest. It was not reported if the patient received a corrective treatment for the events (has been in the er because of pain a swelling (right knee), has been in the er because of pain a swelling). At time of reporting, the outcome was unknown for all events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNVISC
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key12459204
MDR Text Key270997343
Report Number2246315-2021-00145
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberARSP006C
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/13/2021 Patient Sequence Number: 1
-
-