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

Lot Number UNKNOWN

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

Patient Problems Inflammation (1932); Skin Inflammation/ Irritation (4545)

Event Date 09/11/2022

Event Type  Injury  

Event Description

Inflammation was all over her body [inflammation] ([swelling face], [swelling]).Inflammation in both knees [joint inflammation] ([joint swelling]).Applied 6 ml of synvisc (3 synvisc injections of 2ml each) as a single dose/product.Prescribing issue [off label dosing amount].Case narrative: initial information was received from mexico on (b)(6) 2022 regarding an unsolicited valid serious case from a physician.This case is linked to case (b)(4) (same patient, multiple devices).This case involves a 60 years old female patient for whom it was reported that inflammation was all over her body, inflammation in both knees after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Also, applied 6 ml of synvisc (3 synvisc injections of 2ml each) as a single dose/product prescribing issue.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing meniscus tear (knee) and gonarthrosis of second degree almost third degree (knee).On (b)(6) 2022 (saturday), the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection in right knee for meniscus tear and gonarthrosis of second degree almost third degree at dose of 6 ml once (3 synvisc injections of 2ml each as a single dose; product prescribing issue - intensity: mild; off label use of device; latency: same day) (strength, lot, expiry date: unknown).The physician no longer had information on batch number.The technique was performed in a careful and correct manner verifying the return of synovial fluid from her knee by the doctor.The doctor mentioned that he applied 6 ml of synvisc (3 synvisc injections of 2ml each) since it was only a supplementation treatment, since he would later perform surgery on the patient for meniscus tear and gonarthrosis of second degree almost third degree.So, this treatment was only a management option.After the procedure the patient traveled to the beach and the patient contacted doctor on monday to notify him that since sunday ((b)(6) 2022), 1 day after injection, she had presented inflammation in both knees (joint inflammation, required intervention) (joint swelling - intensity: mild, intervention required).Since monday, (b)(6) 2022, 2 days after injection, the inflammation was all over her body (inflammation, required intervention) (swelling - intensity: mild; required intervention) and face (swelling face - intensity: mild; required intervention).The doctor asked the patient if she had consumed seafood, in order to rule out a possible food poisoning; however, the patient denied having consumed seafood during that time.The doctor prescribed a treatment for a possible allergy described as an injection of dexamethasone and antihistamines and after a few hours the patient reported that the inflammation had gone down with the management indicated by the doctor.Additionally, the doctor asked if there was any protocol to treat possible reactions to the medication.He had never seen anything similar happen with any of his other patients.Patient did not experience any additional symptoms/events.There were no lab data/results available.The company suspect product was not inappropriately used as per local marketing authorization.Action taken: not applicable for off label use of device, drug withdrawn (discontinued) for rest both events.The patient was treated with one injection of dexamethasone and antihistamine for inflammation was all over her body, inflammation in both knees.At time of reporting, the outcome was recovered on (b)(6) 2022 for the event inflammation was all over her body and inflammation in both knees, unknown for off label use of device.A product technical complaint was initiated, and results were pending for the same.

Manufacturer Narrative

Sanofi company comment dated 29-sep-2022.This case involves a 60 years old female patient who had inflammation all over her body, and inflammation in both knees after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient received one injection of dexamethasone and antihistamines for the reported events and inflammation had gone down with this treatment.Based on the available information, causal relationship between the events and suspect device as assessed as possibly related due to the feasible temporal gap in the occurrence of events and known safety profile of synvisc one.However, further information regarding patient¿s medical history, allergic history, past medications, and other risk factors would aid in better case assessment.

Event Description

Inflammation was all over her body [inflammation] ([swelling face], [swelling]) inflammation in both knees [joint inflammation] ([joint swelling]) applied 6 ml of synvisc (3 synvisc injections of 2ml each) as a single dose/product prescribing issue [off label use of device] case narrative: initial information was received from mexico on 22-sep-2022 regarding an unsolicited valid serious case from a physician.This case is linked to case 2022sa379284 (same patient, multiple devices).This case involves a 60 years old female patient for whom it was reported that inflammation was all over her body, inflammation in both knees after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Also, applied 6 ml of synvisc (3 synvisc injections of 2ml each) as a single dose/product prescribing issue.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing meniscus tear (knee) and gonarthrosis of second degree almost third degree (knee).On 10-sep-2022 (saturday), the patient received synvisc (hylan g-f 20, sodium hyaluronate) injection in right knee for meniscus tear and gonarthrosis of second degree almost third degree at dose of 6 ml once (3 synvisc injections of 2ml each as a single dose; product prescribing issue - intensity: mild; off label use of device; latency: same day) (strength, lot, expiry date: unknown).The physician no longer had information on batch number.The technique was performed in a careful and correct manner verifying the return of synovial fluid from her knee by the doctor.The doctor mentioned that he applied 6 ml of synvisc (3 synvisc injections of 2ml each) since it was only a supplementation treatment, since he would later perform surgery on the patient for meniscus tear and gonarthrosis of second degree almost third degree.So, this treatment was only a management option.After the procedure the patient traveled to the beach and the patient contacted doctor on monday to notify him that since sunday (11-sep-2022), 1 day after injection, she had presented inflammation in both knees (joint inflammation, required intervention) (joint swelling - intensity: mild, intervention required).Since monday, 12-sep-2022, 2 days after injection, the inflammation was all over her body (inflammation, required intervention) (swelling - intensity: mild; required intervention) and face (swelling face - intensity: mild; required intervention).The doctor asked the patient if she had consumed seafood, in order to rule out a possible food poisoning; however, the patient denied having consumed seafood during that time.The doctor prescribed a treatment for a possible allergy described as an injection of dexamethasone and antihistamines and after a few hours the patient reported that the inflammation had gone down with the management indicated by the doctor.Additionally, the doctor asked if there was any protocol to treat possible reactions to the medication.He had never seen anything similar happen with any of his other patients.Patient did not experience any additional symptoms/events.There were no lab data/results available.The company suspect product was not inappropriately used as per local marketing authorization.Action taken: not applicable for off label use of device, drug withdrawn (discontinued) for rest both events the patient was treated with one injection of dexamethasone and antihistamine for inflammation was all over her body, inflammation in both knees.At time of reporting, the outcome was recovered on 12-sep-2022 for the event inflammation was all over her body and inflammation in both knees, unknown for off label use of device a product technical complaint was initiated, and results were pending for the same.Based on information previously received, the llt was updated to off label use of device.

Manufacturer Narrative

Sanofi company comment dated 29-sep-2022.This case involves a 60 years old female patient who had inflammation all over her body, and inflammation in both knees after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient received one injection of dexamethasone and antihistamines for the reported events and inflammation had gone down with this treatment.Based on the available information, causal relationship between the events and suspect device as assessed as possibly related due to the feasible temporal gap in the occurrence of events and known safety profile of synvisc one.However, further information regarding patient¿s medical history, allergic history, past medications, and other risk factors would aid in better case assessment.

Manufacturer Narrative

Sanofi company comment dated 29-sep-2022.This case involves a 60 years old female patient who had inflammation all over her body, and inflammation in both knees after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].The patient received one injection of dexamethasone and antihistamines for the reported events and inflammation had gone down with this treatment.Based on the available information, causal relationship between the events and suspect device as assessed as possibly related due to the feasible temporal gap in the occurrence of events and known safety profile of synvisc one.However, further information regarding patient¿s medical history, allergic history, past medications, and other risk factors would aid in better case assessment.

Event Description

Inflammation was all over her body [inflammation] ([swelling face], [swelling]) inflammation in both knees [joint inflammation] ([joint swelling]) applied 6 ml of synvisc (3 synvisc injections of 2ml each) as a single dose/product prescribing issue [off label use of device].Case narrative: initial information was received from mexico on 22-sep-2022 regarding an unsolicited valid serious case from a physician.This case is linked to case (b)(4) (same patient, multiple devices).This case involves a 60 years old female patient for whom it was reported that inflammation was all over her body, inflammation in both knees after the use of medical device hylan g-f 20, sodium hyaluronate [synvisc].Also, applied 6 ml of synvisc (3 synvisc injections of 2ml each) as a single dose/product prescribing issue.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing meniscus tear (knee) and gonarthrosis of second degree almost third degree (knee).On (b)(6) 2022 (saturday), the patient received synvisc (hylan g-f 20, sodium hyaluronate) (strength: 48mg/6ml) injection in right knee for meniscus tear and gonarthrosis of second degree almost third degree at dose of 6 ml once (3 synvisc injections of 2ml each as a single dose; product prescribing issue - intensity: mild; off label use of device; latency: same day) (lot, expiry date: unknown).The physician no longer had information on batch number.The technique was performed in a careful and correct manner verifying the return of synovial fluid from her knee by the doctor.The doctor mentioned that he applied 6 ml of synvisc (3 synvisc injections of 2ml each) since it was only a supplementation treatment, since he would later perform surgery on the patient for meniscus tear and gonarthrosis of second degree almost third degree.So, this treatment was only a management option.After the procedure the patient traveled to the beach and the patient contacted doctor on monday to notify him that since sunday (b)(6) 2022, 1 day after injection, she had presented inflammation in both knees (joint inflammation, required intervention) (joint swelling - intensity: mild, intervention required).Since monday, (b)(6) 2022, 2 days after injection, the inflammation was all over her body (inflammation, required intervention) (swelling - intensity: mild; required intervention) and face (swelling face - intensity: mild; required intervention).The doctor asked the patient if she had consumed seafood, in order to rule out a possible food poisoning; however, the patient denied having consumed seafood during that time.The doctor prescribed a treatment for a possible allergy described as an injection of dexamethasone and antihistamines and after a few hours the patient reported that the inflammation had gone down with the management indicated by the doctor.Additionally, the doctor asked if there was any protocol to treat possible reactions to the medication.He had never seen anything similar happen with any of his other patients.Patient did not experience any additional symptoms/events.There were no lab data/results available.The company suspect product was not inappropriately used as per local marketing authorization.Action taken: not applicable for off label use of device, drug withdrawn (discontinued) for rest both events.The patient was treated with one injection of dexamethasone and antihistamine for inflammation was all over her body, inflammation in both knees.At time of reporting, the outcome was recovered on (b)(6) 2022 for the event inflammation was all over her body and inflammation in both knees, unknown for off label use of device.A product technical complaint (ptc) was initiated on 23-sep-2022 for synvisc one (hylan g-f 20, sodium hyaluronate) (batch number: unknown) with global ptc number: (b)(4).The sample status of the ptc was not available and ptc stated: the product lot number was not provided; therefore, a batch record review is not possible.Based on the lack of information provided, no capa (corrective and preventive action) is required.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 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 has not indicated any safety issue.Sanofi will continue to monitor complaints and trending ''product event handling'' to determine if a capa is required.The final investigation was completed on 04-nov-2022 with summarized conclusion as no assessment possible.Based on information previously received, the llt was updated to off label use of device.Additional information was received on 22-sep-2022 from quality department: ptc details with summarized conclusion and suspect strength added.Text was 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: 15512019
• MDR Text Key: 300883701
• Report Number: 2246315-2022-00118
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2023

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: Health Professional
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/25/2022; 04/27/2023
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 60 YR
• Patient Sex: Female