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Lot Number 7RSP018
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arthralgia (2355); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Knee became swollen and very painful, injection site joint pain. Right knee became swollen and very painful, injection site joint swelling. Case narrative: initial information received on (b)(6) 2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc". Patient id: (b)(6). Study title: patient support program involving synvisc. This case is linked to case (b)(6) (same patient). This case involves elderly female patient whose right knee became swollen and very painful while being 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. On (b)(6) 2018 (about two years ago), the patient started taking hylan g-f 20, sodium hyaluronate injection (second injection) in right knee (injection technique: bent knee, lateral injection), liquid solution, strength 16 mg/ 2ml, at a dose of 2 ml thrice intra-articularly ( batch number: 7rsp018 ) for osteoarthritis in right knee. On an unknown date after receiving the second injection, patient reported that her right knee became swollen and very painful (injection site joint swelling) (injection site joint pain) (intensity: moderate) (unknown latency) and she had to receive cortisone. Both the events were leading to intervention. Action taken: no action taken for both events. The patient was treated with cortisone for injection site joint pain and injection site joint swelling. At time of reporting, the outcome was recovered / resolved on an unknown date for both events. A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc (lot number unknown) with global ptc number (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on the lack of information provided, no capa was required. It is 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 will continue to monitor complaints to determine if a capa was required. Final investigation was completed on 22-jul-2021. Reporter causality: related for both events. Company causality: reportable for both events. Based on information previously received, suspect product has been updated from synvisc one to synvisc and the study id was updated from spon_i_synvisc one to spon_i_synvisc. Follow up information received on 13-jul-2021 from physician. Start date of suspect updated. Additional information was received on 22-jul-2021 from other healthcare professional. Ptc results received and processed. Global ptc number was added. Based on information previously received on (b)(6) 2021 from physician. Reporter causality updated to related and reporter details of physician added. Case became medically confirmed.
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Type of DeviceMOZ
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater 08807
MDR Report Key12390548
MDR Text Key268884726
Report Number2246315-2021-00141
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 foreign,health professional,s
Type of Report Initial
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSP018
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? Yes
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1