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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 ejection fraction 20-25% [dilated cardiomyopathy] ([dysrhythmias], [ejection fraction decreased]). Case narrative: initial information was received on 14-dec-2020 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097901. The case was linked with (b)(4) (first injection: right knee), (b)(4) (first injection: left knee), (b)(4) (second injection: right knee), (b)(4) (second injection: left knee), and (b)(4) (third injection: right 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), family history and concomitant medications 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 received intra-articular injection of hylan g-f 20, sodium hyaluronate in left knee (third injection) for arthritis (with an unknown batch number, dose, and frequency). There will be no information available on the batch number of this case. On an unknown date in 1999, after unknown latency, 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 was assessed as medically significant and life threatening. Action taken: not applicable. Corrective treatment: not reported. Outcome: unknown. A product technical complaint (ptc) was initiated on 14-dec-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. Based on the lack of information provided, no capa (corrective and preventive action) was required. 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-conformance) 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 safety surveillance effort to detect safety signals. This review had not indicated any safety issue. Sanofi would continue to monitor complaints as stated in sop (b)(4) "product event handling" to determine if a capa was required. Final investigation was completed on 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: ptc results were received and added to the case. 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 Key11116082
MDR Text Key231579262
Report Number2246315-2021-00010
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
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