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

Lot Number BRSL009A

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 07/13/2021

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated 12-apr-2022: this case involves a female patient who had oedema peripheral and drainage of 60 cc of synovial fluid was done for it after treatment with synvisc one.Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded.However, further information regarding any family history and any relevant medical history of patient, any concurrent conditions and clinical course precludes comprehensive case assessment.

Event Description

Intra-articular edema [edema knees].Allergic reaction/sudden reaction to synvisc [allergic reaction to drug].Marked pain left knee [aching (l) knee].Case narrative: initial information received on 01-apr-2022 from portugal regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves adult female patient who experienced intra-articular edema, allergic reaction/sudden reaction to synvisc and marked pain left knee while being 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) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection at dose 1 iu, frequency and route unknown in left knee (lot - brsl009a, expiry date unknown) for unknown indication.On an unknown date in (b)(6) 2021, after approximate latency of few days, there was allergic reaction/sudden reaction to synvisc (drug hypersensitivity) with marked pain (arthralgia;) and intra-articular edema (oedema peripheral; seriousness criteria: intervention required), having been performed on (b)(6) 2021, the drainage of 60 cc of synovial fluid, with disappearance of the complaints.Currently, the patient was walking without difficulty and with less pain when descending steps, reported having returned to the state prior to the infiltration.It was clarified that two units of hylan g-f 20, sodium hyaluronate were used (same batch), but the allergic reaction only developed with one of them - left knee.The patient had an infiltration in her knee, which, according to them, created an allergic reaction.Action taken: not applicable.Corrective treatment: drainage of 60 cc of synovial fluid for intra-articular edema it was not reported if the patient received a corrective treatment for the events (marked pain left knee, allergic reaction/sudden reaction to synvisc).At time of reporting, the outcome was recovering / resolving for the event marked pain left knee, was not recovered / not resolved for the event intra-articular edema and was unknown for the event allergic reaction/sudden reaction to synvisc.

Event Description

Allergic reaction/sudden reaction to synvisc [device allergy] ([edema knees], [aching (l) knee], [joint aspiration], [knee effusion]).Case narrative: initial information received on 01-apr-2022 from portugal regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an adult female patient who experienced allergic reaction/sudden reaction to synvisc after 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) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection (48 mg/6ml) at dose 1 iu in left knee (lot - brsl009a, expiry date 29-feb-2024) (indication,frequency and route: unknown).On an unknown date in (b)(6) 2021, after approximate latency of few days, there was allergic reaction/sudden reaction to synvisc (device allergy, intervention required) with marked pain (arthralgia, intervention required) and intra-articular edema (oedema peripheral; seriousness criteria: intervention required), having been performed on (b)(6) 2021, the drainage of 60 cc of synovial fluid (joint effusion, aspiration joint, intervention required), with disappearance of the complaints.Currently, the patient was walking without difficulty and with less pain when descending steps, reported having returned to the state prior to the infiltration.It was clarified that two units of hylan g-f 20, sodium hyaluronate were used (same batch), but the allergic reaction only developed with one of them in left knee, caused her serious problems.Therefore, she only asked for the return of the value for that unit, as the injected product was totally wasted, because it had to be removed.The patient had an infiltration in her knee, which, according to them, created an allergic reaction.Action taken: not applicable.Corrective treatment: drainage of 60 cc of synovial fluid.At time of reporting, the outcome was recovering.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 05-apr-2022 for synvisc one.Batch number: brsl009a the production and quality control documentation for lot number brsl009a expiration date (2024-02) was reviewed.The investigation showed that the product met specification.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number brsl009a no capa is 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 has not indicated any safety issue.As of 06-may-2022 there are 3 complaints on file for lot number brsl009 and all related sublots.2 complaints are on file for lot number brsl009a: (1) syringe luer lok system damage and (1) adverse event report.1 complaint is on file for lot number brsl009: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 19-may-2022 with summarized conclusion as no assessment possible additional information was received on 05-apr-2022 and 06-apr-2022 from other healthcare professional (from quality department).Gptc number was added.Additional information was received on 19-may-2022 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, preferred term for allergic reaction/sudden reaction to synvisc was updated from drug hypersensitivity to device allergy.Previously captured diagnosis intra-articular edema, and marked pain left knee were updated as symptoms of event allergic reaction/sudden reaction to synvisc.Overall listedness of case was updated from unlisted to listed.Text was amended accordingly.

Event Description

Allergic reaction/sudden reaction to synvisc [allergic reaction] ([walking difficulty], [injection site joint swelling], [injection site joint pain], [joint aspiration], [injection site joint effusion]) case narrative: initial information was received on 01-apr-2022 from portugal regarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves an adult female patient who had allergic reaction/sudden reaction to synvisc after she was treated with hylan g-f 20, sodium hyaluronate [synvisc one].The patient's past medical treatment(s), vaccination(s) and family history were not provided.The patient had ongoing asthma, allergic rhinitis, venous insufficiency, intestinal diverticula and of course, problems in the knee.Concomitant medications included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (elebrato ellipta); fluticasone furoate (avamys); montelukast sodium (singulair); ebastine (kestine) (all for asthma and allergic rhinitis); acetylsalicylic acid (tromalyt) (circulation) and structomax (knees) on (b)(6) 2021, the patient started taking hylan g-f 20, sodium hyaluronate injection (48 mg/6ml) at dose 1 iu in left knee (lot - brsl009a, expiry date: 29-feb-2024) (indication, frequency, and route: unknown).On same day, the pain (injection site joint pain, caused disability, required intervention) and edema (injection site joint swelling, caused disability, required intervention) started shortly after taking synvisc one.On same day at night, the patient could barely walk and on the next day ((b)(6) 2021) she could only walk with the help of a canadian (gait disturbance, caused disability, required intervention).On (b)(6) 2021, the knee was triple to its normal size (injection site joint swelling, caused disability, required intervention).Reportedly, there was allergic reaction/sudden reaction to synvisc (allergic reaction, caused disability, required intervention) with marked pain and intra-articular edema.On (b)(6) 2021, the drainage of 60 cc of synovial fluid was done (injection site joint effusion, aspiration joint, caused disability, required intervention), with disappearance of the complaints.The knee only returned to normal after the fluid was removed.Currently, the patient was walking without difficulty and with less pain when descending steps, reported having returned to the state prior to the infiltration.It was clarified that two units of hylan g-f 20, sodium hyaluronate were used (same batch), but the allergic reaction only developed with one of them in left knee, caused her serious problems.Therefore, she only asked for the return of the value for that unit, as the injected product was totally wasted, because it had to be removed.The patient had an infiltration in her knee, which, according to them, created an allergic reaction.As of (b)(6) 2022, the patient was feeling reasonably well with respect to reported events it was unknown if the patient experienced any additional symptoms/events.It was unknown if there were lab data/results available.Action taken: not applicable.Corrective treatment: drainage of 60 cc of synovial fluid for joint effusion (due to hypersensitivity) at time of reporting, the outcome was recovering for hypersensitivity.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 05-apr-2022 for synvisc one.Batch number: brsl009a.The production and quality control documentation for lot number brsl009a expiration date (2024-02) was reviewed.The investigation showed that the product met specification.No associated non-conformances were noted.Based on the lot number batch record review & lot number frequency analysis for lot number brsl009a no capa is 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 has not indicated any safety issue.As of 06-may-2022 there are 3 complaints on file for lot number brsl009 and all related sublots.2 complaints are on file for lot number brsl009a: (1) syringe luer lok system damage and (1) adverse event report.1 complaint is on file for lot number brsl009: (1) adverse event report.Sanofi will continue to monitor complaints to determine if a capa is required.The final investigation was completed on 19-may-2022 with summarized conclusion as no assessment possible additional information was received on 05-apr-2022 and 06-apr-2022 from other healthcare professional (from quality department).Gptc number was added.Additional information was received on 19-may-2022 from other healthcare professional (from quality department).Gptc results were received and added.Upon internal review, preferred term for allergic reaction/sudden reaction to synvisc was updated from drug hypersensitivity to device allergy.Previously captured diagnosis intra-articular edema, and marked pain left knee were updated as symptoms of event allergic reaction/sudden reaction to synvisc.Overall listedness of case was updated from unlisted to listed.Text was amended accordingly.Based on the previously received information, downgrade was marked as yes in product tab and event coding was updated from device allergy to hypersensitivity.Additional information was received on 20-jun-2022 from a patient.Symptom added- could barely walk/could only walk with the help of a canadian (gait disturbance).Concomitant medications added.Concurrent conditions added.Clinical course was updated.Text was amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 14088057
• MDR Text Key: 293910925
• Report Number: 2246315-2022-00046
• 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,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/29/2024
• Device Lot Number: BRSL009A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: 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
• Treatment: AVAMYS (FLUTICASONE FUROATE),UNKNOWN.; ELEBRATO ELLIPTA,UNKNOWN.; KESTINE (EBASTINE),UNKNOWN.; SINGULAIR (MONTELUKAST SODIUM),UNKNOWN.; TROMALYT (ACETYLSALICYLIC ACID),UNKNOWN.
• Patient Outcome(s): Disability; Required Intervention
• Patient Sex: Female