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Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Cardiomyopathy (1764); No Code Available (3191)
Event Date 01/01/1999
Event Type  Injury  
Event Description
Dilated cardiomyopathy with ef 20-25% [dilated cardiomyopathy] ([ejection fraction decreased], [dysrhythmias]). Case narrative: the case was linked with (b)(4) (first injection: left knee), (b)(4) (second injection: right knee), (b)(4) (second injection: left knee), (b)(4) (third injection: right knee) and (b)(4) (third injection: left knee) (multiple devices for same patient). Initial information received on (b)(6) 2020 regarding an unsolicited valid serious case received from physician via health authorities of united states under reference mw5097901. This case involves an unknown age female patient who had dilated cardiomyopathy with ef 20-25%, while she was treated with hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that patient was previously well with exception of arthritis (ongoing condition). On an unknown date in 1999, the patient started taking intra-articular injection of hylan g-f 20, sodium hyaluronate in right knee (first injection) (with an unknown batch number, dose, frequency, strength) for arthritis. There will be no information available on the batch number for this case. On an unknown date in 1999, on routine exam patient was found to have an asymptomatic dysrhythmia (arrhythmia). Patient had stress echo, holter and ultimately cardiac cath (catherization) was done. No cad (coronary artery disease) was found. Finding showed dilated cardiomyopathy with ef (ejection fraction) 20-25% (congestive cardiomyopathy with symptom of ejection fraction decreased) (onset: 1999, latency: unknown). Event of congestive cardiomyopathy and its symptoms were assessed as medically significant and the event was also life threatening. Action taken: no action taken. It was not reported if the patient received a corrective treatment. Outcome: unknown. A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc for unknown batch number and global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr (non-conformances report) process. Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required. Investigation completion date: (b)(6) 2020. Follow up was received on (b)(6) 2020 from healthcare professional. Global ptc number added. Text amended accordingly. Additional information was received on (b)(6) 2020 from healthcare professional. Investigational results were added. Text amended accordingly.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater 08807
MDR Report Key11075311
MDR Text Key229832593
Report Number2246315-2020-00180
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 health professional
Type of Report Initial
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
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: 12/28/2020 Patient Sequence Number: 1