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

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

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Event Description

Pulmonary embolism that started in my right leg [pulmonary embolism].Both knees are now giving me a lot of pain [knee pain].Didn't work this time with no adverse event [device ineffective].Case narrative: initial information received on 08-apr-2021, regarding an unsolicited valid serious case received from a patient.This case involves an adult patient who experienced pulmonary embolism that started in my right leg, both knees are now giving me a lot of pain and didn't work this time with no adverse event, while he/she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included a severe left knee injury while re-roofing community hall roof and the only treatment at the time was the removal of the meniscus rather than just trim the rough ages in 1970s, osteoarthritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Other past medical treatment included rooster comb extract to mend or repair cartilage and like a miracle it worked for more ten years.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection in right knee, (dosage, lot number, frequency, route, batch number, indication unknown).The information regarding lot number was requested.On an unknown date, after unknown latency, the right knee acted up and patient was told synvisc now used bacteria to produce the fluid.Didn't work that time (device ineffective).In 2001, ten years ago, long after the use of hylan g-f 20, sodium hyaluronate, the patient developed a pulmonary embolism that started in right leg but that was all over and no longer take any blood thinners(certainly not warfarin) except 100mg of aspirin.This event was assessed as medically significant.On an unknown date, after unknown latency, both knees were now giving a lot of pain (arthralgia) supposedly due to osteoarthritis.The patient was taking arthrozene for three months which was better immediately after but now, nada.The patient was treated with acetylsalicylic acid (aspirin) for pulmonary embolism and boswellia serrata, chicken comb, collagen (arthrozene) for arthralgia.The patient outcome is reported as not applicable for didn't work this time with no adverse event; unknown for rest of the events.A product technical complaint was initiated and results were pending for the same.

Event Description

Pulmonary embolism that started in my right leg [pulmonary embolism] both knees are now giving me a lot of pain [knee pain] didn't work this time with no adverse event [device ineffective] case narrative: this case is deleted following an incorrect worldwide id.The new case (b)(4).Will be submitted with the same information.Initial information was received from united states on 08-apr-2021 regarding an unsolicited valid serious case from a patient.This case involves an adult patient who experienced pulmonary embolism that started in my right leg, both knees are now giving me a lot of pain and didn't work this time with no adverse event, while he/she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included a severe left knee injury while re-roofing community hall roof and the only treatment at the time was the removal of the meniscus rather than just trim the rough ages in 1970s, osteoarthritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Other past medical treatment included rooster comb extract to mend or repair cartiladge and like a miracle it worked for more ten years.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection in right knee, (dosage, lot number, frequency, route, batch number, indication unknown).The information regarding lot number was requested.On an unknown date, after unknown latency, the right knee acted up and patient was told synvisc now used bacteria to produce the fluid.Didn't work that time (device ineffective).In 2001, ten years ago, long long after the use of hylan g-f 20, sodium hyaluronate, the patient developed a pulmonary embolism that started in right leg but that was all over and no longer take any blood thinners(certainly not warfarin) except 100mg of aspirin.This event was assessed as medically significant.On an unknown date, after unknown latency, both knees were now giving a lot of pain (arthralgia) supposedly due to osteoarthritis.The patient was taking arthrozene for three months which was better immediately after but now, nada.The patient was treated with acetylsalicylic acid (aspirin) for pulmonary embolism and boswellia serrata, chicken comb, collagen (arthrozene) for arthralgia.The patient outcome is reported as not applicable for didn't work this time with no adverse event; unknown for rest of the events.A product technical complaint (ptc) was initiated on 08-apr-2021 for synvisc; batch number: unknown; global ptc number: 100118396 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 (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 as stated in sop rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on 26-apr-2021 follow up information received on 08-apr-2021 from other healthcare professional.No significant information.Additional information was received on 26-apr-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

Event Description

Pulmonary embolism that started in my right leg [pulmonary embolism].Both knees are now giving me a lot of pain [knee pain].Didn't work this time with no adverse event [device ineffective].Case narrative: initial information was received from united states on 08-apr-2021 regarding an unsolicited valid serious case from a patient.This case involves an adult patient who experienced pulmonary embolism that started in my right leg, both knees are now giving me a lot of pain and didn't work this time with no adverse event, while he/she was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc).The patient's past medical history included a severe left knee injury while re-roofing community hall roof and the only treatment at the time was the removal of the meniscus rather than just trim the rough ages in 1970s, osteoarthritis.The patient's past medical treatment(s), vaccination(s) and family history were not provided.Other past medical treatment included rooster comb extract to mend or repair cartiladge and like a miracle it worked for more ten years.On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection in right knee, (dosage, lot number, frequency, route, batch number, indication unknown).The information regarding lot number was requested.On an unknown date, after unknown latency, the right knee acted up and patient was told synvisc now used bacteria to produce the fluid.Didn't work that time (device ineffective).In 2001, ten years ago, long long after the use of hylan g-f 20, sodium hyaluronate, the patient developed a pulmonary embolism that started in right leg but that was all over and no longer take any blood thinners(certainly not warfarin) except 100mg of aspirin.This event was assessed as medically significant.On an unknown date, after unknown latency, both knees were now giving a lot of pain (arthralgia) supposedly due to osteoarthritis.The patient was taking arthrozene for three months which was better immediately after but now, nada.The patient was treated with acetylsalicylic acid (aspirin) for pulmonary embolism and boswellia serrata, chicken comb, collagen (arthrozene) for arthralgia.The patient outcome is reported as not applicable for didn't work this time with no adverse event; unknown for rest of the events.A product technical complaint (ptc) was initiated on 08-apr-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 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 (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 as stated in sop rdg-sop-000440 "product event handling" to determine if a capa is required.Final investigation was completed on 26-apr-2021.Follow up information received on 08-apr-2021 from other healthcare professional.No significant information.Additional information was received on 26-apr-2021 from other healthcare professional.Gptc results were received and added.Text was amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 11672522
• MDR Text Key: 262865354
• Report Number: 2246315-2021-00092
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/04/2021; 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention