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

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

Patient Problems Pain (1994); Disability (2371); Reaction (2414)

Event Type  Injury  

Event Description

Not be able to work [inability to work].Continue to have dull pain [pain dull].Severe side effects from synvisc shot [adverse drug reaction nos].Case narrative: initial information was received on 08-jan-2021 regarding an unsolicited valid serious case from patient via health authorities of united states under reference mw5097712.This case involves an adult patient (gender: unknown) who received medical device hylan g-f 20, sodium hyaluronate (synvisc) and was not be able to work, continue to have dull pain and severe side effects from synvisc shot.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 synvisc (hylan g-f 20, sodium hyaluronate) shot via intra-articular route (dose, frequency, indication and lot - unknown).Information on lot number was requested.On (b)(6) 2020, after unknown latency, the patient had pain (pain).On an unknown date, after unknown latency, the patient had severe side effects (s/e) from synvisc shot (adverse drug reaction).The patient asked that who was going to be responsible for suffering, pain and expenses due to severe side effects from synvisc shot.The patient continued to have (l) dull pain (pain) and not be able to work (impaired work ability; latency: unknown), at the time of report.The event of impaired work ability was leading to disability.Final diagnosis was severe side effects, continue to have dull pain and not be able to work.Action taken: unknown for all the events.It was not reported if the patient received a corrective treatment.The patient outcome is reported unknown for severe side effects; not recovered for rest both events.A product technical complaint (ptc) was initiated on 08-jan-2021 for synvisc.Batch number: unknown; global ptc number: (b)(4).The product lot number was not provided; therefore, a batch record review is not possible.Based on lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: 25-jan-2021.Follow up was received on 13-jan-2021 from healthcare professional.Global ptc number was added.Text amended accordingly.Additional information was received on 25-jan-2021 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC
• 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: 11257061
• MDR Text Key: 229576109
• Report Number: 2246315-2021-00054
• 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: health professional
• Type of Report: Initial
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: 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
• Patient Outcome(s): Required Intervention; Disability