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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment for dated 12-jan-2022: this case involves adult male patient who receive treatment with hylan g-f 20, sodium hyaluronate (synvisc).The causal relationship with suspect cannot be denied for medically significant event allergic reaction.However, lack of information regarding concurrent illness, past drugs, personal, family and lifestyle history precludes comprehensive assessment of the case.The case will be reevaluated on receive of follow up information.

Event Description

Allergic reaction ([knee swelling], [joint effusion]).Case narrative: initial information from (b)(6) received on 04-jan-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves adult male patient who had allergic reaction 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 an unknown date, the patient started using hylan g-f 20, sodium hyaluronate with unknown dosage formulation, frequency, strength, route, batch number, indication.It was reported that they had synvisc injections several years ago.However, this time they had an allergic reaction (hypersensitivity) (medically significant) (onset and latency: unknown).The patient's knee became swollen (joint swelling) and needed draining (joint effusion).Action taken: unknown.Corrective treatment: needed draining for knee became swollen.Outcome: unknown.

Event Description

Allergic reaction [allergic reaction] ([knee swelling], [joint effusion]).Case narrative: initial information from canada received on (b)(6) 2022 regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves adult male patient who had allergic reaction 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 an unknown date, the patient started using hylan g-f 20, sodium hyaluronate (strength 16 mg/2 ml) with unknown dosage formulation, frequency, route, batch number, indication.It was reported that they had synvisc injections several years ago.However, this time they had an allergic reaction (hypersensitivity) (medically significant) (onset and latency: unknown).The patient's knee became swollen (joint swelling) and needed draining (joint effusion).Action taken: unknown.Corrective treatment: needed draining for knee became swollen.Outcome: unknown.A product technical complaint (ptc) was initiated with global ptc number: (b)(4) on (b)(6) 2022 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 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.Final investigation complete date was 18-jan-2022.No safety issues were indicated in this review.Sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 "product event handling" to determine if a capa was required.Additional information was received on 18-jan-2022 from the other healthcare professional.Global ptc number and text amended accordingly.Text amended accordingly.

• 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: 13266433
• MDR Text Key: 289063659
• Report Number: 2246315-2022-00003
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/24/2022
• 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): Other; Required Intervention
• Patient Sex: Male