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 Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/09/2021

Event Type  Injury  

Manufacturer Narrative

Sanofi company comment dated (b)(6) 2022: this case involves a 62 years old male patient whose doctor injected the shot did hit a vein with the last one with the use of medical device hylan g-f 20, sodium hyaluronate [synvisc one].Based on the available information, causal relationship between the events and suspect product could not be denied.However, further information regarding patient¿s medical history, past medications, concomitant medications, post injection routine, injection technique and other risk factors would aid in better case assessment.

Event Description

The doctor who injected the shot did hit a vein with the last one [venous injury] , couldn't walk for several days [walking difficulty] , severe pain after the injection (right knee) [injection site joint pain], inflammation (right knee) [joint inflammation] , there was some blood squirting [injection site bleeding].Case narrative: initial information received on (b)(6) 2022 from (b)(6) regarding an unsolicited valid serious case received from the patient.This case involves a 62 years old male patient whose doctor injected the shot did hit a vein with the last one, couldn't walk for several days, severe pain after the injection (right knee), inflammation (right knee), there was some blood squirting 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.In (b)(6) 2021, the patient received synvisc one injection at a dose of 6 ml once in his right knee via intra-articular route (lot, expiry date, strength - unknown) for osteoarthritis.Patient had three synvisc-one injections over the last three years in the right knee for osteoarthritis.Patient also said that the doctor who injected the shot did hit a vein with the last one (venous injury; same day latency) (medically significant).There was some blood squirting (injection site haemorrhage; same day latency).The last one resulted in severe pain after the injection (injection site joint pain) and inflammation (arthritis), especially the first night (latency same day for both).Patient couldn't walk for several days (gait disturbance; unknown latency).He believed the last injection was in (b)(6) 2021.He also mentioned that about a week later, the pain/inflammation (arthritis) went away and the injection worked well as it did the first two times.He said that it was now starting wear off.Action taken: not applicable.Corrective treatment: not reported for all the events.Outcome: recovered / resolved for all the events.A product technical complaint (ptc) was initiated, and the results were pending for the same.

Event Description

The doctor who injected the shot did hit a vein with the last one (right knee) [venous injury].Couldn't walk for several days [walking difficulty].Severe pain after the injection (right knee) [injection site joint pain].Inflammation (right knee) [joint inflammation].There was some blood squirting [injection site bleeding].Inflamed synovitis in right knee [synovitis of knee].Case narrative: initial information received on 26-oct-2022 from canada regarding an unsolicited valid serious case received from the patient.This case involves a 62 years old male patient whose doctor injected the shot did hit a vein with the last one (right knee), couldn't walk for several days, severe pain after the injection (right knee), inflammation (right knee), there was some blood squirting and inflamed synovitis in right knee 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.In (b)(6) 2021, the patient received synvisc one injection at a dose of 6 ml once in his right knee via intra-articular route having the strength 48mg/6ml (lot, expiry date - unknown) for osteoarthritis.Patient had three synvisc-one injections over the last three years in the right knee for osteoarthritis.Patient also said that the doctor who injected the shot did hit a vein with the last one (venous injury; same day latency) (medically significant).There was some blood squirting (injection site haemorrhage; same day latency).The last one resulted in severe pain after the injection (injection site joint pain) and inflammation (arthritis), especially the first night (latency same day for both).Patient couldn't walk for several days (gait disturbance; unknown latency).He believed the last injection was in (b)(6) 2021.He also mentioned that about a week later, the pain/inflammation (arthritis) went away and the injection worked well as it did the first two times.He said that it was now starting wear off.And the doctor diagnosed it as an inflamed synovitis in his right knee (synovitis; onset and latency: unknown).Now it had been almost a year and it seemed the effect was wearing off.That can exclude him from another shot in future.Action taken: not applicable for all events.Corrective treatment: not reported for all the events.Outcome: unknown for the event synovitis and recovered / resolved for all the events.A product technical complaint (ptc) was initiated on (b)(6) 2022 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available.Complaint was set in process.A product technical complaint (ptc) was initiated on 26-oct-2022 for synvisc one (lot/batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not received and the ptc stated: the product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective and preventive action) 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 (non-conformance) 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.Sanofi will continue to monitor complaints and trending to determine if a capa was required.The final investigation was completed on 04-nov-2022 with summarized conclusion as no assessment possible.Additional information was received on 04-nov-2022 from the quality department.Ptc details and strength was added.Upon internal review on 04-nov-2022 case (b)(4) be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in case id (b)(4).Additionally event synovitis was also added.

Event Description

The doctor who injected the shot did hit a vein with the last one (right knee) [venous injury] couldn't walk for several days [walking difficulty] severe pain after the injection (right knee) [injection site joint pain] inflammation (right knee) [joint inflammation] there was some blood squirting [injection site bleeding] inflamed synovitis in right knee [synovitis of knee].Case narrative: initial information received on 26-oct-2022 from canada regarding an unsolicited valid serious case received from patient.This case involves a 62 years old male patient whose doctor injected the shot did hit a vein with the last one (right knee), couldn't walk for several days, severe pain after the injection (right knee), inflammation (right knee), there was some blood squirting and inflamed synovitis in right knee 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.In (b)(6) 2021, the patient received synvisc one injection at a dose of 6 ml once in his right knee via intra-articular route having the strength 48mg/6ml (lot, expiry date - unknown) for osteoarthritis.Patient had three synvisc-one injections over the last three years in the right knee for osteoarthritis.Patient also said that the doctor who injected the shot did hit a vein with the last one (venous injury; same day latency) (medically significant).There was some blood squirting (injection site haemorrhage; same day latency).The last one resulted in severe pain after the injection (injection site joint pain) and inflammation (arthritis), especially the first night (latency same day for both).Patient couldn't walk for several days (gait disturbance; unknown latency).He believed the last injection was in (b)(6) 2021.He also mentioned that about a week later, the pain/inflammation (arthritis) went away and the injection worked well as it did the first two times.He said that it was now starting wear off.And the doctor diagnosed it as an inflamed synovitis in his right knee (synovitis; onset and latency: unknown).Now it had been almost a year and it seemed the effect was wearing off.That can exclude him from another shot in future.Action taken: not applicable for all events.Corrective treatment: not reported for all the events.Outcome: unknown for the event synovitis and recovered / resolved for all the events.A product technical complaint (ptc) was initiated on 26-oct-2022 for synvisc one with global ptc number (b)(4) (batch: unknown).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 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 did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.The final investigation was completed on 16-nov-2022 and investigation conclusion was no assessment possible.The complaint (b)(4) has been canceled for the following reason: duplicate complaint.The complaint (b)(4) has been canceled for the following reason as it was duplicate complaint.Additional information was received on 04-nov-2022 from the quality department.Ptc details and strength was added.Upon internal review on 04-nov-2022 (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the (b)(4) (to be deleted) has been merged in case (b)(4).Additionally, event synovitis was also added.Additional information was received on 04-nov-2022 from the quality department.Ptc details added.Text amended accordingly.Additional information received on 15-nov-2022 from quality department.Ptc details updated.Text amended accordingly.Additional information received on 16-nov-2022 from quality department.Ptc details updated.Text amended accordingly.

Event Description

The doctor who injected the shot did hit a vein with the last one (right knee) [venous injury] couldn't walk for several days [walking difficulty] inflammation (right knee)/ inflamed synovitis in right knee/had synov [injection site synovitis] ([injection site joint pain]) there was some blood squirting [injection site bleeding] case narrative: initial information received on 26-oct-2022 from canada regarding an unsolicited valid serious case received from physician (case is considered as medically confirmed).This case is linked to case (b)(4) (duplicate).This case involves a 62 years old male patient whose doctor injected the shot did hit a vein with the last one (right knee), couldn't walk for several days and inflammation (right knee)/ inflamed synovitis in right knee/had synovitis 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 received synvisc one injection at a dose of 6 ml once in his right knee via intra-articular route having the strength 48mg/6ml (lot, expiry date - unknown) for osteoarthritis.Patient also said that the doctor who injected the shot did hit a vein with the last one (venous injury; same day latency; onset date: (b)(6) 2021) (medically significant).There was some blood squirting (injection site haemorrhage; same day latency; onset date: 09-dec-2021) (medically significant).Just a bandage was needed for vein injury (and no other treatment).The last one resulted in severe pain after the injection (injection site joint pain; onset date: (b)(6) 2021) and inflammation especially the first night (latency same day for both).Patient couldn't walk for several days (gait disturbance; unknown latency).The patient consulted the doctor.The doctor diagnosed it as an inflamed synovitis in his right knee (injection site joint inflammation; onset and latency: unknown).That can exclude him from another shot in future.He gave him an injection against pain next day.The patient was fine after one week, the pain/inflammation went away and the injection worked well as it did the first two times.Now in (b)(6) 2022, it had been almost a year and it seemed the effect was wearing off.Action taken: not applicable for all events corrective treatment: not reported for all the events outcome: recovering for the event synovitis and recovered / resolved for all the events.A product technical complaint (ptc) was initiated on 26-oct-2022 for synvisc one with global ptc number (b)(4) (batch: unknown).The product lot number was not provided; therefore, a batch record review was not possible.Based on the lack of information provided, no capa (corrective action and preventive action) 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 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 did not indicate any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.The final investigation was completed on 16-nov-2022 and investigation conclusion was no assessment possible.The complaint (b)(4) has been canceled for the following reason: duplicate complaint the complaint (b)(4) has been canceled for the following reason as it was duplicate complaint.Additional information was received on 04-nov-2022 from the quality department.Ptc details and strength was added.Upon internal review on 04-nov-2022 case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4)(to be deleted) has been merged in case id (b)(4).Additionally, event synovitis was also added.Additional information was received on 04-nov-2022 from the quality department.Ptc details added.Text amended accordingly.Additional information received on 15-nov-2022 from quality department.Ptc details updated.Text amended accordingly.Additional information received on 16-nov-2022 from quality department.Ptc details updated.Text amended accordingly.Additional information was received on 17-nov-2022 from the physician.Suspected start date was updated from nov-2021 to 09-dec-2021.Text amended accordingly.Upon internal review on 10-jun-2023, case (b)(4) (to be deleted) was identified to be duplicate of (b)(4) (to be retained).Hence, all the information from the case (b)(4) (to be deleted) has been merged in the case (b)(4).Case (b)(4) received with clock start date of 09-nov-2022 would be deleted.(detail all changes here done in merger case as pert of merger process).

• Brand Name: SYNVISC ONE
• 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: 15723064
• MDR Text Key: 303037084
• Report Number: 2246315-2022-00133
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• 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 the Reporter a Health Professional?: Yes
• 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; Other
• Patient Sex: Male