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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number ARSL021
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Fluid that was pulled 3 times from 40-150ml [joint effusion], acute inflammation in the knee,inflammation is getting worse [joint inflammation] ([condition worsened]), fever gets worse [fever] ([condition aggravated]). Case narrative: initial information received on 11-oct-2021 from poland regarding an unsolicited valid serious case received from a patient mother. This case involves a (b)(6) female patient who experienced fluid that was pulled 3 times from 40-150ml, acute inflammation in the knee, inflammation is getting worse and fever gets worse with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection dosage, frequency, route unknown (lot - unk). The information regarding lot number was requested. On an unknown date in 2021, after unknown latency, there was acute inflammation in the knee (arthritis), there was fluid that was pulled 3 times from 40-150ml (joint effusion; intervention required). Then arthroscopy was performed, until (b)(6) 2021, the inflammation was getting worse (condition aggravated). The inflammation lasted for the 6th month, the fever got worse (pyrexia and condition aggravated; start date: 2021 and latency unknown), the patient was afraid of sepsis. Relevant laboratory test results included: aspiration joint - in 2021: [40-150ml], arthroscopy: inflammation was worse. Corrective treatment: joint aspiration- fluid that was pulled 3 times from 40-150ml, not reported for rest of the events. At time of reporting, the outcome was not recovered / not resolved for all events.
 
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Brand NameSYNVISC ONE
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 Key12655008
MDR Text Key283845212
Report Number2246315-2021-00166
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 Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberARSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 10/19/2021 Patient Sequence Number: 1
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