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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Missed Dose (2561)
Event Date 03/11/2020
Event Type  Injury  
Event Description
Missed dose (2 weeks late on his second dose) with no adverse event [missed dose]. Case narrative: initial information received on 07-may-2020 regarding an unsolicited valid serious case received from health authorities of united states via patient (mw5094209). This case involves an unknown age male patient started treatment with hylan g-f 20, sodium hyaluronate (synvisc) and missed dose (2 weeks late on his second dose) with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date in 2020, the patient started treatment with hylan g-f 20, sodium hyaluronate injection (strength 8 mg/ml) and received his first 2 ml dose via intra articular route (batch number unknown) for unknown indication. Information on batch number was not requested in context of covid 19 crisis. On (b)(6) 2020, after unknown latency, patient missed dose and he was 2 weeks late on his second dose (medically significant). It was reported that he never received week 4 dose that was shipped to mdo on an unknown date in 2020, due to mdo being closed. Consultation dose on missed dose and it was advised to patient that label would be for maintenance dose due to second dose week four had been shipped to mdo. No more information provided. Action taken: not applicable. It was not reported if the patient received a corrective treatment. The patient outcome is reported as not applicable a product technical compliant (ptc) was initiated on (b)(6) 2020 for synvisc with 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 was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result is identified and mitigated through the ncr process. Sanofi global pharmacovigilance and epidemiology continuously monitors 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 has not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Investigation complete date: (b)(6) 2020. Additional information was received on 14-may-2020 from healthcare professional. Ptc 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 Key10122475
MDR Text Key195723344
Report Number2246315-2020-00064
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 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
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: 06/05/2020 Patient Sequence Number: 1