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

Lot Number BRSL011

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Anxiety (2328); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2021

Event Type  Injury  

Event Description

Likely allergic to it/allergic reaction [device allergy] ([joint stiffness], [injection site itching], [swelling of l knee], [aching (l) knee], [joint range of motion decreased], [joint warmth], [joint inflammation], [effusion (l) knee], [arthrocentesis]), pain was shooting [shooting pain], very anxious [anxiety], couldn't sleep [difficulty sleeping].Case narrative: initial information received on 06-aug-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from (b)(6).This case involves a (b)(6) female patient who was likely allergic to it/allergic reaction, pain was shooting, very anxious and couldn't sleep 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.In (b)(6) 2021, the patient received treatment with hylan g-f 20, sodium hyaluronate injection (dose, frequency, route unknown) ( batch number: brsl011, expiry date- 29-feb-2024)) for left knee arthritis in left knee.Specialist said for couple weeks it would be sore but then it would improve.On (b)(6) 2021, after latency of approx.Few days, it went ballistic (joint swelling), it went to stiff (joint stiffness), she could not bend or straighten it (joint range of motion decreased).Specialist said she was likely allergic to it (device allergy), it was quite itchy, and when he took the fluid out that spot was very itchy (injection site pruritus) and painful (arthralgia).Patient further reported an allergic/inflammatory reaction (arthritis) two-three weeks following the synvisc-one injection as she had pain, stiffness, swelling and heat (joint warmth).On (b)(6) 2021, she went to emergency for 5 hours, they did x-rays and such and saw the specialist on the (b)(6) 2021, drained all the fluid out (joint effusion and aspiration joint) and he was sending it to see if it was infected and being examined for pathogens, therefore she was currently awaiting follow up with him for this.Last night on (b)(6) 2021, after latency of approx.1 month, pain was shooting (pain) so much that she could not sleep (insomnia).Doctor gave pain relievers but nothing helped and she was very anxious (anxiety).Patient was asking if it was possible to get a refund.Action taken: not applicable for all events.Corrective treatment: pain relievers for pain; not reported for rest events.At time of reporting, the outcome was unknown for all events.Seriousness criteria: medically significant and intervention required for device allergy.

Event Description

Likely allergic to it/allergic reaction [device allergy] ([joint stiffness], [injection site itching], [swelling of l knee], [aching (l) knee], [joint range of motion decreased], [joint warmth], [joint inflammation], [effusion (l) knee], [arthrocentesis]).Pain was shooting [shooting pain].Very anxious [anxiety].Couldn't sleep [difficulty sleeping].Case narrative: initial information received on 06-aug-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from canada.This case involves a 70 years old female patient who was likely allergic to it/allergic reaction, pain was shooting, very anxious and couldn't sleep 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.In (b)(6) 2021, the patient received treatment with hylan g-f 20, sodium hyaluronate injection, liquid (solution) (strength: 48mg/6ml) (dose, frequency, route unknown) ( batch number: brsl011, expiry date- 29-feb-2024)) for left knee arthritis in left knee.Specialist said for couple weeks it would be sore but then it would improve.On (b)(6) 2021, after latency of approx.Few days, it went ballistic (joint swelling), it went to stiff (joint stiffness), she could not bend or straighten it (joint range of motion decreased).Specialist said she was likely allergic to it (device allergy), it was quite itchy, and when he took the fluid out that spot was very itchy (injection site pruritus) and painful (arthralgia).Patient further reported an allergic/inflammatory reaction (arthritis) two-three weeks following the synvisc-one injection as she had pain, stiffness, swelling and heat (joint warmth).On (b)(6)2021, she went to emergency for 5 hours, they did x-rays and such and saw the specialist on the 04-aug-2021, drained all the fluid out (joint effusion and aspiration joint) and he was sending it to see if it was infected and being examined for pathogens, therefore she was currently awaiting follow up with him for this.Last night on (b)(6) 2021, after latency of approx.1 month, pain was shooting (pain) so much that she could not sleep (insomnia).Doctor gave pain relievers but nothing helped and she was very anxious (anxiety).Patient was asking if it was possible to get a refund.Action taken: not applicable for all events.Corrective treatment: pain relievers for pain; not reported for rest events.At time of reporting, the outcome was unknown for all events.Seriousness criteria: medically significant and intervention required for device allergy and its symptoms.A product technical complaint was initiated on 06-aug-2021 for synvisc one.Batch number: brsl011 global ptc number: (b)(4).The production and quality control documentation for lot brsl011 expiration date (2024-02) 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 brsl011 no capa (corrective and preventive action) 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 25-aug-2021 there were 5 complaints on file for lot brsl011 and all related sublots.3 complaints were on file for lot brsl011: (1) adverse event report/packaging issue, (1) adverse event report and (1) leakage.1 complaint was on file for lot brsl011a: (1) packaging issue.1 complaint was on file for lot brsl011b: (1) adverse event report.Sanofi would continue to monitor if a capa is required.Investigation complete date: 26-aug-2021 additional information was received on 26-aug-2021 from other healthcare professional.Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 12310595
• MDR Text Key: 282226183
• Report Number: 2246315-2021-00138
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Lot Number: BRSL011
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention