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

Lot Number 9RSL014

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

Patient Problem Arthralgia (2355)

Event Date 03/03/2020

Event Type  Injury  

Event Description

She was in a lot of pain; as soon as she had the injection it started to hurt [injection site joint pain] , some swelling (right knee) [injection site joint swelling] synvisc one used for indication: spur [drug use for unapproved indication].Case narrative: initial information received on 18-oct-2021 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: (b)(6).Study title: patient support program involving synvisc one.This case involves a (b)(6) years old female patient who experienced she was in a lot of pain; as soon as she had the injection it started to hurt, some swelling (right knee) and synvisc one used for indication: spur 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) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection 6 ml dose (lot - 9rsl014) in right knee for a "spur" (growth) (product use in unapproved indication).On (b)(6) 2020, on the same day, the patient was in a lot of pain; as soon as she had the injection it started to hurt (injection site joint pain), some swelling (right knee) (injection site joint swelling).The patient tolerated the pain for approximately five weeks then received a cortisone injection which stopped the pain.This event of injection site joint pain was leading to intervention.Reportedly, the patient did not recall the exact date of the injection but did say it was the only time she had a synvisc injection.Action taken: not applicable.The patient was treated with cortisone for injection site joint pain and not reported for rest of the events.At time of reporting, the outcome was unknown for the event synvisc one used for indication: spur; recovered for rest of the events.Reporter causality: related for all the events.Company causality: not reportable for product use in unapproved indication; reportable for rest both events.

Event Description

She was in a lot of pain; as soon as she had the injection it started to hurt [injection site joint pain], some swelling (right knee) [injection site joint swelling], synvisc one used for indication: spur [drug use for unapproved indication].Case narrative: initial information received on 18-oct-2021 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".Patient id: unknown; country: canada.Study title: patient support program involving synvisc one.This case involves a 73 years old female patient who experienced she was in a lot of pain; as soon as she had the injection it started to hurt, some swelling (right knee) and synvisc one used for indication: spur 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) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48mg/ 6 ml) 6 ml dose (lot - 9rsl014) in right knee for a "spur" (growth) (product use in unapproved indication).On (b)(6) 2020, on the same day, the patient was in a lot of pain; as soon as she had the injection it started to hurt (injection site joint pain), some swelling (right knee) (injection site joint swelling).The patient tolerated the pain for approximately five weeks then received a cortisone injection which stopped the pain.This event of injection site joint pain was leading to intervention.Reportedly, the patient did not recall the exact date of the injection but did say it was the only time she had a synvisc injection.Action taken: not applicable.The patient was treated with cortisone for injection site joint pain and not reported for rest of the events.At time of reporting, the outcome was unknown for the event synvisc one used for indication: spur; recovered for rest of the events.Product technical complaint (ptc) was initiated with global ptc number (b)(4) on 19-oct-2021 for product dupilumab.Batch number; unknown; sample status: not available.The investigation was in process.Reporter causality- related for all the events.Company causality- not reportable for product use in unapproved indication; reportable for rest both events.Additional information received on 19-oct-2021 from other healthcare professional.Formulation, strength and global ptc number added.Text amended.

Event Description

She was in a lot of pain; as soon as she had the injection it started to hurt [injection site joint pain] some swelling (right knee) [injection site joint swelling] synvisc one used for indication: spur [drug use for unapproved indication] case narrative: initial information received on 18-oct-2021 regarding a solicited valid serious case received from a patient, in the scope of post-marketing sponsored study "spon_i_synvisc one".(b)(6).Study title: patient support program involving synvisc one.This case involves a 73 years old female patient who experienced she was in a lot of pain; as soon as she had the injection it started to hurt, some swelling (right knee) and synvisc one used for indication: spur 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) 2020, the patient started taking hylan g-f 20, sodium hyaluronate injection liquid (solution) (strength: 48mg/ 6 ml) 6 ml dose (lot - 9rsl014) in right knee for a "spur" (growth) (product use in unapproved indication).On (b)(6) 2020, on the same day, the patient was in a lot of pain; as soon as she had the injection it started to hurt (injection site joint pain), some swelling (right knee) (injection site joint swelling).The patient tolerated the pain for approximately five weeks then received a cortisone injection which stopped the pain.This event of injection site joint pain was leading to intervention.Reportedly, the patient did not recall the exact date of the injection but did say it was the only time she had a synvisc injection.Action taken: not applicable.The patient was treated with cortisone for injection site joint pain and not reported for rest of the events.At time of reporting, the outcome was unknown for the event synvisc one used for indication: spur; recovered for rest of the events a product technical complaint (ptc) was initiated with global ptc number (b)(4) on (b)(6) 2021 for product dupilumab.Batch number; 9rsl014.Sample status: not available the production and quality control documentation for lot # 9rsl014 expiration date (2022-04) was reviewed.The investigation showed that the product met specifications.No associated non-conformance were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 9rsl014 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 (b)(6) 2021 thereare 6 complaints on file for lot# 9rsl014 and all related sublots.6 complaintsare on file for lot# 9rsl014: (6) adverse event reports.Sanofi will continue to monitor complaints to determine if a capa is required.The investigation was completed on 15-nov-2021 with conclusion summarized as no assessment possible.Reporter causality- related for all the events company causality- not reportable for product use in unapproved indication; reportable for rest both events additional information received on 19-oct-2021 from other healthcare professional.Formulation, strength and global ptc number added.Text amended.Additional information was received on 15-nov-2021 from the quality department.Ptc results received and processed.Text amended accordingly.

• Brand Name: SYNVISC ONE
• 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: 12697831
• MDR Text Key: 278371208
• Report Number: 2246315-2021-00167
• 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,Study,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 9RSL014
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female