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Lot Number J808
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Nausea (1970); Myalgia (2238); Shaking/Tremors (2515); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/24/1998
Event Type  Injury  
Event Description
Infection [infection nos], became weak and shaky [weakness], became weak and shaky [shaking], nausea [nausea], muscle aching [muscle ache], felt rapid heart beat [heart rate increased], synvisc 2 ml in right knee intraarticular as 1st injection for r. A. (rheumatoid arthritis) [off label use of device]. Case narrative: initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from a physician via health authorities of united states under reference mw5097840. This case involves an adult patient (gender: unknown) who experienced infection, became weak and shaky, nausea, muscle aching, felt rapid heart beat and after receiving hylan g-f 20, sodium hyaluronate (synvisc) 2 ml in right knee intraarticular as 1st injection for r. A. (rheumatoid arthritis) (off label use of device). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient received synvisc (hylan g-f 20, sodium hyaluronate) at dose of 2 ml in right knee via intra-articular route as 1st injection for rheumatoid arthritis (considered as off label use of device; latency: same day) (lot - j808, expiration date: 01-sep-2000) (frequency: unknown). On (b)(6) 1998, after unknown latency, the patient had infection, became weak (asthenia) and shaky (tremor), muscle aching (myalgia) and nausea, also felt rapid heart beat (heart rate increased) that lasted approximately 30 hours then subsided. The patient had no rash and local knee. These events were assessed as medically significant. Final diagnosis was felt rapid heart beat, muscle aching, nausea, became weak and shaky, infection and synvisc 2 ml in right knee intraarticular as 1st injection for r. A. (rheumatoid arthritis). Action taken: not applicable for off label use of device; unknown for rest all events it was not reported if the patient received a corrective treatment. The patient outcome is reported as recovered for felt rapid heart beat, not applicable for off label use of device; unknown for rest all events product technical complaint (ptc) was initiated with global ptc number (b)(4) on 08-jan-2021 for product. Batch number; unknown. Device not returned. 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 report) 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 had not indicated any safety issue. Sanofi will continue to monitor adverse events to determine if a capa is required. Final investigation complete date: 22-jan-2021. Follow up information was received on 11-jan-2021. Comet id number added. No significant information added. Additional information was received on 22-jan-2021 from healthcare professional. Global ptc results added. Text was 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 Key11257566
MDR Text Key233155738
Report Number2246315-2021-00058
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,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/01/2000
Device Lot NumberJ808
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: 02/01/2021 Patient Sequence Number: 1