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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Numbness (2415); Ambulation Difficulties (2544)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Leg pain [leg pain]. Numbness [numbness]. Headache [headache]. Case narrative: initial information received on 17-nov-2021 from united states regarding an unsolicited valid serious case received from a sales representative. This case involves adult female patient who experienced leg pain, numbness and headache with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On (b)(6) -2021, the patient started using hylan g-f 20, sodium hyaluronate, (solution for injection) (strength: 48 mg/ ml) (route, indication, frequency, dose: unknown) in the left knee. On the unknown date of 2021, after the unknown latency of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced leg pain (pain in extremity), numbness (hypoaesthesia) and headache. On (b)(6) 2021, patient received steroid injection. Action taken: not applicable for all the events. Corrective treatment: not reported for headache; steroid for numbness and leg pain. Outcome: unknown for all the events. Seriousness criteria: intervention required (steroid) for numbness and leg pain. Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 17-nov-2021 for product. Batch number; unknown sample status: not available 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: 01-dec-2021 with summary code as no assessment possible. Additional information was received on 17-nov-2021 from the quality department. Global ptc number added. Formulation and strength added. Text amended accordingly. Additional information was received on 01-dec-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 Key12959256
MDR Text Key287258891
Report Number2246315-2021-00178
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
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: 12/08/2021 Patient Sequence Number: 1