MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC; MOZ

Lot Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 07/16/2021

Event Type  Injury  

Event Description

Injection site joint swelling [injection site joint swelling].Case narrative: this case is cross linked with case: (b)(4) (multiple device).Initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional) from united states.This case involves a (b)(6) years old male patient who experienced injection site joint swelling with the use of medical device 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) 2021, the patient received first injection hylan g-f 20, sodium hyaluronate, at the dose of 8 mg/ml(formulation, batch number, route, frequency: unknown).On (b)(6) 2021, the patient received second injection hylan g-f 20, sodium hyaluronate, at the dose of 8 mg/ml (formulation, batch number, route, frequency: unknown) for swelling in knee.On (b)(6) 2021, after the latency of 24 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced injection site joint swelling (disability).Action taken: unknown.It was not reported if the patient received a corrective treatment for the event (injection site joint swelling).At time of reporting, the outcome was unknown for the event swelling in knee.

Event Description

Injection site joint swelling/ swelling and discomfort in the injection area after both applications [injection site joint swelling] swelling and discomfort in the injection area after both applications [injection site joint discomfort] synvisc used for swelling in knee [product use in unapproved indication] case narrative: this case is cross linked with case: (b)(4) (multiple device).Initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional) from united states.This case involves a 60 years old male patient who experienced injection site joint swelling/ swelling and discomfort in the injection area after both applications, synvisc used for swelling in knee, swelling and discomfort in the injection area after both applications with the use of medical device 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) 2021, the patient received first injection hylan g-f 20, sodium hyaluronate, at the dose of 8 mg/ml(formulation, batch number, route, frequency: unknown).On (b)(6) 2021, the patient received second injection hylan g-f 20, sodium hyaluronate, at the dose of 8 mg/ml (formulation, batch number, route, frequency: unknown) for swelling in knee (synvisc used for swelling in knee: product use in unapproved indication).On (b)(6) 2021, after the latency of 24 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced injection site joint swelling (disability).Reportedly, the patient had swelling and discomfort in the injection area after both applications (injection site joint discomfort).Action taken: not applicable for synvisc used for swelling in knee and unknown for rest of the events.It was not reported if the patient received a corrective treatment for the event ( injection site joint swelling).At time of reporting, the outcome was unknown for all the events.Additional information was received on 20-jul-2021 from the non-healthcare professional.Events added for synvisc used for swelling in knee, swelling and discomfort in the injection area after both applications.Verbatim updated for injection site joint swelling/ swelling and discomfort in the injection area after both applications.Clinical course was updated.Text amended accordingly.

Event Description

Injection site joint swelling/ swelling and discomfort in the injection area after both applications [injection site joint swelling] swelling and discomfort in the injection area after both applications [injection site joint discomfort] synvisc used for swelling in knee with no reported ae [device use in unapproved indication] case narrative: this case is cross linked with case: (b)(4) (multiple devices suspect for same patient).Initial information received on 20-jul-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp (non health care professional) from united states.This case involves a 60 years old male patient who experienced injection site joint swelling/ swelling and discomfort in the injection area after both applications, synvisc used for swelling in knee with no reported ae(adverse event), swelling and discomfort in the injection area after both applications with the use of medical device 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) 2021, the patient received first injection hylan g-f 20, sodium hyaluronate at the dose of 8 mg/ml(formulation, batch number, route, frequency: unknown).On (b)(6) 2021, the patient received second injection hylan g-f 20, sodium hyaluronate of strength 16 mg/2 ml, at the dose of 8 mg/ml (formulation, batch number, route, frequency: unknown) for swelling in knee (synvisc used for swelling in knee: device use issue).Information on the batch number and expiry date cannot be requested on (b)(6) 2021, latency: same day of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced injection site joint swelling (disability).Reportedly, the patient had swelling and discomfort in the injection area after both applications (injection site joint discomfort) (disability).Action taken: not applicable for device use issue and unknown for rest of the events.It was not reported if the patient received a corrective treatment for both events.At time of reporting, the outcome was unknown for all the events.A product technical complaint (ptc) was initiated on 16-jul-2021 for synvisc.Batch number; unknown global ptc number: 100333316.Sample status of ptc was not available and ptc stated complaint: adverse event preliminary assessment ((b)(4)).Based on the complaint from intake team, there was no quality related defect that would attribute to a malfunction, death, or serious injury.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.The defect class has been updated to ii.Investigation (tj 07jun2023).The product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment was possible.It is 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 nonconforming material.Sanofi will continue to monitor adverse events and perform trend analysis to determine if a capa(corrective and preventive actions) was required.The final investigation was completed on 13-jun-2023 with summarized conclusion as no assessment possible additional information was received on 20-jul-2021 from the non-healthcare professional.Events added for synvisc used for swelling in knee, swelling and discomfort in the injection area after both applications.Verbatim updated for injection site joint swelling/ swelling and discomfort in the injection area after both applications.Clinical course was updated.Text amended accordingly.Additional information was received on 13-jun-2023 by quality department: ptc complete details added; strength added; text amended.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer (Section G): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive, ms 55b-220; a; bridgewater 08807
• MDR Report Key: 12242486
• MDR Text Key: 266401800
• Report Number: 2246315-2021-00129
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• 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 Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Sex: Male