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

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

Patient Problems Extravasation (1842); Neuropathy (1983); Arthralgia (2355); No Code Available (3191)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Neuropathy [neuropathy nos].Lymphedema [lymphedema].Wrapped her knee so tight that all the fluid form the synvisc injection came out [injection site extravasation] ([incomplete dose administered]) in so much pain she can hardly sit [aching (r) knee] ([joint range of motion decreased]) case narrative: initial information from united states received on 18-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a (b)(6) years old female patient who experienced neuropathy, lymphedema, wrapped her knee so tight that all the fluid form the synvisc injection came out and in so much pain she can hardly sit, while she was 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.Patient had a history of using injections (unspecified) that worked well.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection, once (dose, route and batch number unknown) for osteoarthritis of the right knee.On (b)(6) 2020, after same day latency in the afternoon, home health care came and wrapped her knee because she had neuropathy (neuropathy peripheral; event assessed as serious due to medically significant) and lymphedema (lymphoedema).It was reported that home health care wrapped her knee so tight that all the fluid form the hylan g-f 20, sodium hyaluronate injection came out (injection site extravasation) (incorrect dose administered).Patient reported that now she was in so much pain (arthralgia) that she could hardly sit (joint range of motion decreased).Patient was also requesting for replacement of hylan g-f 20, sodium hyaluronate injection.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.The patient outcome is reported as unknown for all events.

Event Description

Neuropathy [neuropathy nos].Lymphedema [lymphedema].Wrapped her knee so tight that all the fluid form the synvisc injection came out [injection site extravasation] ([incomplete dose administered]).Can hardly walk [walking difficulty].In so much pain she can hardly sit/having so much pain [aching (r) knee] ([joint range of motion decreased]).Case narrative: initial information from united states received on 18-nov-2020 regarding an unsolicited valid serious case from a patient via call center.This case involves a 81 years old female patient who experienced neuropathy, lymphedema, wrapped her knee so tight that all the fluid form the synvisc injection came out, can hardly walk in so much pain she can hardly sit/having so much pain, while she was 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.Patient had a history of using injections (unspecified) that worked well.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection, once (dose, route and batch number unknown) for osteoarthritis of the right knee.On (b)(6) 2020, after same day latency in the afternoon, home health care came and wrapped her knee because she had neuropathy (neuropathy peripheral; event assessed as serious due to medically significant) and lymphedema (lymphoedema).It was reported that home health care wrapped her knee so tight that all the fluid form the hylan g-f 20, sodium hyaluronate injection came out (injection site extravasation) (incorrect dose administered).Patient reported that now she was in so much pain (arthralgia) that she could hardly sit (joint range of motion decreased) (onset: 2020; latency unknown).Patient was also requesting for replacement of hylan g-f 20, sodium hyaluronate injection.On an unknown date in 2020, after unknown latency, patient was having so much pain (arthralgia) and she could hardly walk (gait disturbance).Patient wanted to get her hylan g-f 20, sodium hyaluronate injection now but her insurance company was not letting the consumer get the hylan g-f 20, sodium hyaluronate until later.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.Outcome: unknown for all events.A product technical complaint (ptc) was initiated on 18-nov-2020 for synvisc one.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 lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result was identified and mitigated through the ncr (non-conformances report) process.Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, 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.Investigation complete date: 23-nov-2020 additional information was received on 23-nov-2020 from other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.Additional information was received on 14-dec-2020 from patient.Event of can hardly walk added with details.Verbatim of event in so much pain she can hardly sit was updated to in so much pain she can hardly sit/having so much pain.Clinical course updated.Text amended accordingly.Follow up information was received on 14-dec-2020 from healthcare professional.Global ptc number added.Follow up information was received on 23-dec-2020 from healthcare professional.Global ptc number (b)(4) was voided as a duplicate.Additionally, upon internal review, the follow up information provided by patient on 14-dec-2020 was marked as significant for device.Text amended accordingly.

Event Description

Neuropathy [neuropathy nos].Lymphedema [lymphedema] wrapped her knee so tight that all the fluid form the synvisc injection came out injection site extravasation; incomplete dose administered.In so much pain she can hardly sit.Aching (r) knee joint range of motion decreased.Case narrative: initial information from united states received on (b)(6) 2020, regarding an unsolicited valid serious case from a patient via call center.This case involves a 81 years old female patient who experienced neuropathy, lymphedema, wrapped her knee so tight that all the fluid form the synvisc injection came out and in so much pain she can hardly sit, while she was 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.Patient had a history of using injections (unspecified) that worked well.On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate, solution for injection, once (dose, route and batch number unknown) for osteoarthritis of the right knee.On (b)(6) 2020, after same day latency in the afternoon, home health care came and wrapped her knee because she had neuropathy (neuropathy peripheral; event assessed as serious due to medically significant) and lymphedema (lymphoedema).It was reported that home health care wrapped her knee so tight that all the fluid form the hylan g-f 20, sodium hyaluronate injection came out (injection site extravasation) (incorrect dose administered).Patient reported that now she was in so much pain (arthralgia) that she could hardly sit.Joint range of motion decreased onset: 2020; latency unknown.Patient was also requesting for replacement of hylan g-f 20, sodium hyaluronate injection.Action taken: not applicable for all events.It was not reported if the patient received a corrective treatment for all events.The patient outcome is reported as unknown for all events a product technical complaint (ptc) was initiated on (b)(6) 2020 ,for synvisc one.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 lack of information provided, no capa (corrective and preventive action) was required.It was the requirement to review all finished batch records for specification conformation prior to release.Any out of specification result is identified and mitigated through the ncr (non-conformances report) 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 surveillance effort to detect safety signals.This review did not indicate any safety issue.Sanofi would continue to monitor if a capa is required.Investigation complete date: (b)(6) 2020.Additional information was received on (b)(6) 2020.From other healthcare professional (genzyme event management group).Global ptc number and its results were added.Clinical course updated.Text amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 10884086
• MDR Text Key: 218970657
• Report Number: 2246315-2020-00160
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention