MAUDE Adverse Event Report: SYNVISC; MOZ

Lot Number UNKNOWN

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

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

Almost fainted [faint].Leg cramps [leg cramps].Lack of efficacy; really didn't help her [lack of drug effect].Case narrative: initial information received on 02-mar-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "(b)(6)".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc.This case involves adult female patient who almost fainted, had leg cramps and lack of efficacy; really didn't help her, 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 injection at a dose of 2 ml once (lot - unknown) for injury.She said that she only got one of the three injections being she had leg cramps (muscle spasms) and almost fainted (syncope; this event was considered medically significant) after receiving the injection (latency: unknown).Patient also said that it really didn't help her (device ineffective).Action taken: drug withdrawn for almost fainted, had leg cramps; not applicable for device ineffective.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on an unknown date for leg cramps and almost fainted; not applicable for device ineffective.Reporter causality: not reported for all events.Company causality: not reportable for device ineffective; reportable for other events.

Event Description

Almost fainted [faint].Leg cramps [leg cramps].Lack of efficacy; really didn't help her [lack of drug effect].Case narrative: initial information received on 02-mar-2021 regarding a solicited valid serious case received from the patient, in the scope of post-marketing sponsored study "spon_i_synvisc".Patient id: unknown; country: canada.Study title: patient support program involving synvisc.This case involves adult female patient who almost fainted, had leg cramps and lack of efficacy; really didn't help her, 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 injection at a dose of 2 ml once (lot - unknown) for injury.She said that she only got one of the three injections being she had leg cramps (muscle spasms) and almost fainted (syncope; this event was considered medically significant) after receiving the injection (latency: unknown).Patient also said that it really didn't help her (device ineffective).Action taken: drug withdrawn for almost fainted, had leg cramps; not applicable for device ineffective.It was not reported if the patient received a corrective treatment.The patient outcome is reported as recovered / resolved on an unknown date for leg cramps and almost fainted; not applicable for device ineffective.A product technical complaint (ptc) was initiated on 02-mar-2021 for synvisc, batch number: unknown with global ptc 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 was identified and mitigated through the ncr process.Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers and assessed 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.Sanofi will continue to monitor adverse events to determine if a capa is required.Final investigation was completed on 18-mar-2021.Reporter causality: not reported for all events.Company causality: not reportable for device ineffective; reportable for other events follow up information received on 02-mar-2021 from healthcare professional.Global ptc number added.Additional information was received on 18-mar-2021 from healthcare professional.Ptc results added.

• Brand Name: SYNVISC
• Type of Device: MOZ
• MDR Report Key: 11432505
• MDR Text Key: 238644621
• Report Number: 2246315-2021-00083
• 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: 03/23/2021

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: No Information
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention