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

Lot Number 9RSL040

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Reaction in her right knee [ill-defined disorder].Case narrative: initial information received on 26-jun-2020 and 29-jun-2020 (processed with clock start date: (b)(6) 2020) from canada regarding an unsolicited valid serious case received from a physician.This case involves a female patient (unknown age) who experienced reaction in her right knee, while she was 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) 2020, the patient started taking hylan g-f 20, sodium hyaluronate, solution for injection in right knee (dosage, frequency, route unknown) (lot - 9rsl040) for unknown indication.On an unknown date in 2020, after unknown latency, the patient had a reaction in her right knee.The patient was admitted into the hospital and was given iv (intravenous) antibiotics to flush it out.This event was leading to intervention.The patient was hospitalized for this event.Action taken: unknown.Corrective treatment: iv antibiotics.The patient outcome is reported as unknown for reaction in her right knee.A product technical complaint (ptc) was initiated and results were pending for the same.

Event Description

Reaction in her right knee [ill-defined disorder].Case narrative: upon internal review on 02-jul-2020, the case updated to non-valid (as only event of unspecified ill defined disorder in the case) and suspect updated to synvisc one from synvisc.Initial information received on 26-jun-2020 and 29-jun-2020 (processed with clock start date:(b)(6) 2020) from canada regarding an unsolicited non-valid serious case received from a physician.This case involves a female patient (unknown age) who experienced reaction in her right knee, while she was treated with 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) 2020, the patient started taking hylan g-f 20, sodium hyaluronate, solution for injection in right knee (dosage, frequency, route unknown) (batch number- 9rsl040; expiry date: sep-2022) for unknown indication.On an unknown date in 2020, after unknown latency, the patient had a reaction in her right knee.The patient was admitted into the hospital and was given iv (intravenous) antibiotics to flush it out.This event was leading to intervention.The patient was hospitalized for this event.Action taken: unknown.Corrective treatment- iv antibiotics.The patient outcome is reported as unknown for reaction in her right knee.A product technical complaint was initiated on (b)(6) 2020 for synvisc one.Batch number: 9rsl040 global ptc number: (b)(4).The production and quality control documentation for lot 9rsl040 expiration date (2022-09) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot batch record review & lot frequency analysis for lot 9rsl040 no capa was required.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.As of(b)(6) 2020 there were two complaints on file for lot 9rsl040 and all related sublots.2 complaints were on file for lot 9rsl040: (1) adverse event report and (1) device issue sanofi would continue to monitor complaints as stated in sop rdg-sop-000440 product event handling to determine if a capa is required final investigation complete date: (b)(6) 2020.Follow up information received on 02-jul-2020.Global ptc number added.No significant information.Additional information received on 02-jul-2020 and 06-jul-2020 (processed together with 02-jul-2020) from other healthcare professional.Upon internal review, the case updated to non-valid (as only event of unspecified ill defined disorder in the case) and suspect updated to synvisc one from synvisc.Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Local comments: downgrade.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10223468
• MDR Text Key: 203331913
• Report Number: 2246315-2020-00074
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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 Operator: No Information
• Device Expiration Date: 09/01/2022
• Device Lot Number: 9RSL040
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention