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

Event Description

Can't work/disabled [inability to work] subjected to falling all the time [falling] experienced pain when they received the injection [pain during injection] synvisc (hylan g-f 20), 300mg, subcutaneous with no adverse event [incorrect dose administered] synvisc (hylan g-f 20), 300mg, subcutaneous with no adverse event [wrong route of administration] case narrative: initial information received on 02-nov-2023 regarding a solicited valid case received from a patient, in the scope of patient support program "psp_saus.Tjo.012", this case became serious on (b)(6) 2024 patient id:(b)(4); country: united states study title: sanofi patient connection.This case involves 68 years old female patient who can't work/disabled, subjected to falling all the time, experienced pain when they received the injection while being treated with hylan g-f 20, sodium hyaluronate [synvisc].She received synvisc (hylan g-f 20) at a dose of 300mg, subcutaneous with no adverse event reported directly linked to incorrect dose administered and wrong route of administration.The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concurrent conditions or risk factors and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection at a dose of 300 mg (incorrect dose administered) via subcutaneous route (incorrect route of product administration) (latency: same day) (with strength: 16mg/2ml, an unknown batch number, expiry date, frequency and indication).Information on batch number, expiry date can not be requested as product has been discarded on an unknown date , latency: same day, patient experienced pain when they received the injection (injection site pain).On an unknown date and latency , patient was disabled.She can't work (impaired work ability; seriousness criteria: disability).She was subjected to falling all the time (fall).Action taken: no action taken for injection site pain, impaired work ability and fall it was not reported if the patient received a corrective treatment for injection site pain, impaired work ability and fall at time of reporting, the outcome was unknown for injection site pain, impaired work ability and fall reporter causality: not reported for all events.Company causality: reportable for injection site pain and not reportable for rest of the events.A product technical complaint (ptc) was initiated on (b)(6) 2023 for synvisc (batch number: unknown) with global ptc number 100374214.The sample status was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.(rc 06nov23) investigation: (rc 15nov23) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is 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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on (b)(6) 2023 with summarized conclusion as no assessment possible.Additional information was received on 15-nov-2023 from healthcare professional (quality department).Ptc results along with strength were added.Text amended accordingly.Additional information was received on 23-feb-2024 from patient: based on this information, the case initially considered as non-serious was upgraded to serious.Event of fall, impaired work ability added; overall company causality was updated from reportable to not reportable; text amended accordingly.

Event Description

Can't work/disabled [inability to work] experienced pain when they received the injection [pain during injection] subjected to falling all the time [falling] keloids arthritis [arthritis] head injury [head injury] knee pain [knee pain] synvisc (hylan g-f 20), 300mg, subcutaneous with no adverse event [incorrect dose administered] synvisc (hylan g-f 20), 300mg, subcutaneous with no adverse event [wrong route of administration].Case narrative: initial information received on (b)(6) 2023 regarding a solicited valid case received from a patient, in the scope of patient support program "psp_saus.Tjo.012", this case became serious on (b)(6) 2024.Study title: sanofi patient connection.This case involves 68 years old female patient who can't work/disabled, subjected to falling all the time, experienced pain when they received the injection, keloids arthritis, knee pain and head injury while being treated with hylan g-f 20, sodium hyaluronate [synvisc].She received synvisc (hylan g-f 20) at a dose of 300mg, subcutaneous with no adverse event reported directly linked to incorrect dose administered and wrong route of administration.The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications, concurrent conditions or risk factors and family history were not provided.On an unknown date, the patient started taking hylan g-f 20, sodium hyaluronate injection at a dose of 300 mg (incorrect dose administered) via subcutaneous route (incorrect route of product administration) (latency: same day) (with strength: 16mg/2ml, an unknown frequency and indication).On an unknown date latency: same day, patient experienced pain when they received the injection (injection site pain) (with unknown batch number and expiry date).On an unknown date and latency, patient was disabled and she can't work (impaired work ability; seriousness criteria: disability).She was subjected to falling all the time (fall) (with unknown batch number and expiry date).Information on batch number, expiry date can not be requested as product has been discarded.Upon follow-up, on an unknown date (latency: unknown), the patient had keloids arthritis (arthritis), knee pain (arthralgia) and had a head injury (with unknown batch number and expiry date).It was also reported that patient was taking the injection 4 times a year, when the medication should only to be taken 2 times a year.Action taken: no action taken for all the events.It was not reported if the patient received a corrective treatment for all the events.At time of reporting, the outcome was unknown for all the events.Reporter causality: not reported for all events.Company causality: reportable for injection site pain and not reportable for rest of the events.A product technical complaint (ptc) was initiated on 02-nov-2023 for synvisc (batch number: unknown) with global ptc number (b)(4).The sample status was not available.Ptc stated: preliminary assessment: based on the complaint from intake team, there is no quality related defect that would attribute to a malfunction a death or serious injury.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.The defect class has been updated to ii.((b)(6) 2023).Investigation: ((b)(6) 2023) the product lot number was not provided.A batch record review is not possible.Based on the lack of information, no assessment is possible.It is 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 nonconforming material or product process.Sanofi will continue to monitor adverse events and perform trend analysis on a periodic basis to determine if a capa (corrective and preventive action) is required.The final investigation was completed on 15-nov-2023 with summarized conclusion as no assessment possible.Additional information was received on 15-nov-2023 from healthcare professional (quality department).Ptc results along with strength were added.Text amended accordingly.Additional information was received on 23-feb-2024 from patient: based on this information, the case initially considered as non-serious was upgraded to serious.Event of fall, impaired work ability added; overall company causality was updated from reportable to not reportable; text amended accordingly.Additional information was received on 15-apr-2024 from patient: new events (arthritis, arthralgia and head injury) added.Clinical course was updated and text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• 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: 18796376
• MDR Text Key: 336404879
• Report Number: 2246315-2024-00016
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2024

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 Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2024
• 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
• Patient Sex: Female