MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE; 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 Date 09/13/2021

Event Type  Injury  

Event Description

Had to use a wheel chair to get back the car once getting the injection [wheelchair user].Injection did not help her [lack of drug effect].Synvisc one used for rheumatoid arthritis [product use in unapproved indication].Case narrative: initial information received on 29-sep-2021 from cregarding an unsolicited valid serious case received from a consumer/non-hcp.This case involves a (b)(6) years old female patient who experienced had to use a wheel chair to get back the car once getting the injection, injection did not help her and synvisc one used for rheumatoid arthritis 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.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection, dosage unknown (lot - unk) for osteoarthritis and rheumatoid arthritis (synvisc one used for rheumatoid arthritis- product use in unapproved indication).The patient had to use a wheel chair to get back the car once getting the injection (wheelchair user).This event was leading to disability.The family physician gave injection and patient also mentioned that the injection did not help her (drug ineffective).Action taken- not applicable.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all events.

Event Description

Had to use a wheel chair to get back the car once getting the injection/ had to use a wheelchair for 1 hour [wheelchair user].Could not get up after the injection [difficulty in standing].Injection hurt [injection site joint pain].Injection did not help her [device ineffective].Synvisc one used for rheumatoid arthritis [product use in unapproved indication].Case narrative: initial information received on 29-sep-2021 from regarding an unsolicited valid serious case received from a consumer/non-hcp from canada.This case involves a 74 years old female patient who experienced had to use a wheel chair to get back the car once getting the injection/ had to use a wheelchair for 1 hour, could not get up after the injection, injection did not help her, injection hurt and synvisc one used for rheumatoid arthritis 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.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6 ml), at a dose of 6 ml once (lot - unknown) for osteoarthritis/ arthrosis and rheumatoid arthritis (synvisc one used for rheumatoid arthritis- product use in unapproved indication).It was reported that injection hurt (injection site joint pain; onset: (b)(6) 2021; latency: same day) and patient could not get up after the injection (dysstasia; onset: (b)(6) 2021; latency: same day), the patient had to use a wheelchair to get back the car once getting the injection (wheelchair user; onset: (b)(6) 2021; latency: same day).This event was leading to disability.Patient had to use wheelchair for 1 hour.The family physician gave injection and patient also mentioned that the injection did not help her (drug ineffective; onset: (b)(6) 2021; latency: same day).Action taken- not applicable for all events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product dupilumab.Batch number; unknown; sample status: not available.The investigation was in process.Additional information was received on 29-sep-2021 from healthcare professional.Global ptc number, formulation and strength were added.Event of injection site pain, dysstasia added.Suspect dose added.Text was amended accordingly.

Event Description

Had to use a wheel chair to get back the car once getting the injection/ had to use a wheelchair for 1 hour [wheelchair user] could not get up after the injection [difficulty in standing] injection hurt [injection site joint pain] injection did not help her [device ineffective] synvisc one used for rheumatoid arthritis [product use in unapproved indication] case narrative: initial information received on (b)(6) 2021 from regarding an unsolicited valid serious case received from a consumer/non-hcp from canada.This case involves a 74 years old female patient who experienced had to use a wheel chair to get back the car once getting the injection/ had to use a wheelchair for 1 hour, could not get up after the injection, injection did not help her, injection hurt and synvisc one used for rheumatoid arthritis 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.On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48 mg/ 6 ml), at a dose of 6 ml once (lot - unknown) for osteoarthritis/ arthrosis and rheumatoid arthritis (synvisc one used for rheumatoid arthritis- product use in unapproved indication).It was reported that injection hurt (injection site joint pain; onset: (b)(6) 2021; latency: same day) and patient could not get up after the injection (dysstasia; onset: (b)(6) 2021; latency: same day), the patient had to use a wheelchair to get back the car once getting the injection (wheelchair user; onset: (b)(6) 2021; latency: same day).This event was leading to disability.Patient had to use wheelchair for 1 hour.The family physician gave injection and patient also mentioned that the injection did not help her (drug ineffective; onset: (b)(6) 2021; latency: same day).Action taken- not applicable for all events.It was not reported if the patient received a corrective treatment for the events.At time of reporting, the outcome was unknown for all events.A product technical complaint (ptc) was initiated on (b)(6) 2021 for synvisc one.Batch number: unknown; comet compliant id number: (b)(4).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 (b)(6) 2021.No safety issues were indicated in this review.Additional information was received on 29-sep-2021 from healthcare professional.Global ptc number, formulation and strength were added.Event of injection site pain, dysstasia added.Suspect dose added.Text was amended accordingly.Additional information was received on 11-oct-2021 from the quality department.Ptc results added.Clinical course updated and 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: 12574535
• MDR Text Key: 274718236
• Report Number: 2246315-2021-00162
• 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,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability