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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] ([dysrhythmias], [ejection fraction decreased]). Case narrative: initial information received on 14-dec-2020 regarding an unsolicited valid serious case received from physician via health authorities of united states under reference mw5097901. The case was linked with (b)(4) (first injection: right 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). 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 left 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 14-dec-2020 for synvisc. Batch number: unknown; global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on lack of information provided, no capa (corrective and preventive action) was required. It was the requirement to review all finished batch records for specification conformation prior to release. Any out of specification result was identified and mitigated through the ncr (non-conformances report) process. Sanofi global pharmacovigilance and epidemiology would continuously monitor adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals. This review did not indicate any safety issue. Sanofi would continue to monitor if a capa was required. Investigation complete date: 04-jan-2021. Follow up was received on 14-dec-2020 from healthcare professional. Global ptc number was added. Text amended accordingly. Additional information was received on 04-jan-2021 from other healthcare professional (genzyme event management group). Global ptc number and its results were added. Clinical course updated. 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 Key11115804
MDR Text Key231579478
Report Number2246315-2021-00003
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 01/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
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: 01/05/2021 Patient Sequence Number: 1