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

Lot Number 7RSPO18A

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

Patient Problems Unspecified Infection (1930); Nausea (1970); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)

Event Date 06/24/2018

Event Type  Injury  

Event Description

Infection in my appendix [appendicitis] ([fever], [abdominal pain]); foot of colon had necrosed/gastrointestinal necrosis [large intestine necrosis] ; unable to walk [unable to walk] ; nauseous [nauseous] ; injected knee swelled up/knee began swelling again [knee swelling] ; pain [knee pain] ; removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations [knee effusion].Case narrative: this unsolicited case from united states was received on (b)(6) 2018 from a patient.This case involves a male patient of unknown age who received treatment with synvisc and later after 16 days injected knee swelled up/knee began swelling again, after 30 days had infection in appendix, foot of colon had necrosed/gastrointestinal necrosis, was unable to walk, was nauseous, got removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations, had pain, the patient's past medical history included blood triglycerides increased, keratomileusis and arthralgia.The patient's past medical treatment included codeine- itching.The patient's past vaccination(s) and family history were not provided.Concomitant medications included lisinopril (lisinopril) for blood pressure abnormal; and gemfibrozil (gemfibrozil) for blood triglycerides abnormal.On (b)(6) 2018, the patient received treatment with intraarticular synvisc injection (dose, frequency, indication, batch/lot number 75po192, 7rspo18a and expiry date: sep-2020) into right knee.On (b)(6) 2018, the patient received synvisc injection.It was reported that the patient had received 3 synvisc injections.On (b)(6) 2018, the patient's injected knee swelled up.On (b)(6) 2018, the patient was unable to walk.On an unknown date in (b)(6) 2018, the patient's doctor removed over 120cc of fluid from his knee and said that would probably be it.The patient's knee began swelling again that night and he drove over an hour each way the next day to have more fluid removed.It was reported that the patient went out of town to visit his son for father's day and could only sit on his lazy boy due to knee swelling.On an unknown date in 2018, the patient experienced pain.On (b)(6) 2018, the patient went to the emergency room where the doctor against his better judgement removed over 100 cc of fluid again to relieve him of pain.It was reported that the patient spent the next day icing elevating and talking over the counter pain medicines.On (b)(6) 2018, after 24 days, the patient went to work where he was nauseous for the entire week.On (b)(6) 2018, in the morning the patient went to the er, they ct scanned and found infection in his appendix and a foot of my colon had necrosed/gastrointestinal necrosis.On the same day, patient had pain and fever.They removed a foot of colon and appendix.The patient spent two weeks in the hospital and had been recuperating at home the past two weeks.The patient's surgeon went through colon issue with him and told him that it was a mystery in that issue it usually appears in the other side of the colon and the reasons that cause this condition normally tested negative for.The patient told her of his bad experience with the injections, following symptoms and she said it's a possibility this spread to his colon to cause this.As there was no other physical explanation the coincidence and timing could not be overlooked.On (b)(6) 2018, the patient recovered foot of colon had necrosed and infection in my appendix.Further it was reported that the patient underwent surgery for both the events and was hospitalized for a duration of 13 days.It was reported that the reactions occurred after the patient received the third injection of synvisc on (b)(6) 2018.On an unknown date in 2018, patient was recovered from nausea, pain, injected knee swelled up/knee began swelling again.Action taken: drug withdrawn corrective treatment: fluid removed from knee, had 3 aspirations for injected knee swelled up/knee began swelling again and removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again; fluid removed from knee, icing elevating and talking otc pain medicines for pain; removed appendix for infection in appendix, abdominal surgery and various medication (unspecified); removed a foot of colon for foot of colon had necrosed; not reported for unable to walk and nauseous outcome: unknown for unable to walk and recovered for all other events a pharmaceutical technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc with global ptc number: (b)(4) 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 monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: hospitalization/prolongation and disability for foot of colon had necrosed and infection in my appendix additional information was received on 30-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information received on 01-aug-2018 from patient.Product lot number added with injection details.Event details and outcome updated for foot of colon had necrosed and infection in my appendix.Verbatim updated for removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations to removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again.Seriousness criterion of disability added.Clinical course updated.Text amended accordingly.Additional information was received on 20-aug-2018 from patient.Event verbatim of removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations was updated from removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations.Event outcome for removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations, pain, injected knee swelled up/knee began swelling again, nauseous was updated from unknown to recovered.Corrective treatment was added for infection in my appendix, symptoms were added for same and hospitalization start date was added.Action taken was updated to drug withdrawn.Expiration date was added.Medical history and concomitant medications were added.Clinical course updated.Text amended accordingly.Follow up information was received on 11-sep-2018.No new information received.

Event Description

Infection in my appendix [appendicitis].([abdominal pain], [fever]).Foot of colon had necrosed/gastrointestinal necrosis/necrosed colon [large intestine necrosis].Unable to walk [unable to walk].Nauseous [nauseous].Injected knee swelled up/knee began swelling again [knee swelling].Pain [knee pain].Removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations [knee effusion].Case narrative: this unsolicited case from united states was received on (b)(6) 2018 from a patient.This case involves a male patient of unknown age who received treatment with synvisc and later after 16 days injected knee swelled up/knee began swelling again, after 30 days had infection in appendix, foot of colon had necrosed/gastrointestinal necrosis/necrosed colon, was unable to walk, was nauseous, got removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations, and had pain.The patient's past medical history included blood triglycerides increased, keratomileusis and arthralgia.The patient's past medical treatment included codeine- itching.The patient's past vaccination(s) and family history were not provided.Concomitant medications included lisinopril (lisinopril) for blood pressure abnormal; and gemfibrozil (gemfibrozil) for blood triglycerides abnormal.On (b)(6) 2018, the patient received treatment with intraarticular synvisc injection (dose, frequency, indication, batch/lot number 75p0192, 7rspo18a and expiry date: sep-2020) into right knee.On (b)(6) 2018, the patient received synvisc injection.It was reported that the patient had received 3 synvisc injections.On (b)(6) 2018, the patient's injected knee swelled up.On (b)(6) 2018, the patient was unable to walk (local).On an unknown date in (b)(6) 2018, the patient's doctor removed over 120cc of fluid from his knee and said that would probably be it.The patient's knee began swelling again that night and he drove over an hour each way the next day to have more fluid removed.It was reported that the patient went out of town to visit his son for father's day and could only sit on his lazy boy due to knee swelling.On an unknown date in 2018, the patient experienced pain.On (b)(6) 2018, the patient went to the emergency room where the doctor against his better judgement removed over 100 cc of fluid again to relieve him of pain.It was reported that the patient spent the next day icing elevating and talking over the counter pain medicines.On (b)(6) 2018, after 24 days, the patient went to work where he was nauseous for the entire week followed by abdominal pain and fever.On (b)(6) 2018, in the morning the patient went to the er, they ct scanned and found infection in his appendix and a foot of my colon had necrosed/gastrointestinal necrosis.On the same day, patient had pain and fever.They removed a foot of colon and appendix.The patient spent two weeks in the hospital and had been recuperating at home the past two weeks.The patient's surgeon went through colon issue with him and told him that it was a mystery in that issue it usually appears in the other side of the colon and the reasons that cause this condition normally tested negative for.The patient told her of his bad experience with the injections, following symptoms and she said it's a possibility this spread to his colon to cause this.As there was no other physical explanation the coincidence and timing could not be overlooked.On (b)(6) 2018, the patient recovered foot of colon had necrosed and infection in my appendix.On (b)(6) 2018, further it was reported that the patient underwent surgery for both the events and was hospitalized for a duration of 13 days.It was reported that the reactions occurred after the patient received the third injection of synvisc on (b)(6) 2018.On an unknown date in 2018, patient was recovered from nausea, pain, injected knee swelled up/knee began swelling again.Action taken: drug withdrawn.Corrective treatment: fluid removed from knee, had 3 aspirations for injected knee swelled up/knee began swelling again and removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again; fluid removed from knee, icing elevating and talking otc pain medicines for pain; removed appendix for infection in appendix, abdominal surgery and various medication (unspecified); foot of colon had necrosed/gastrointestinal necrosis/necrosed colon; not reported for unable to walk and nauseous.Outcome: unknown for unable to walk and recovered for all other events.A pharmaceutical technical complaint (ptc) was initiated on (b)(6) 2018 for synvisc with global ptc number: 54841.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 monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: hospitalization/prolongation and disability for foot of colon had necrosed/gastrointestinal necrosis/necrosed colon and infection in my appendix.Additional information was received on 30-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information received on (b)(6) 2018 from patient.Product lot number added with injection details.Event details and outcome updated for foot of colon had necrosed and infection in my appendix.Verbatim updated for removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations to removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again.Seriousness criterion of disability added.Clinical course updated.Text amended accordingly.Additional information was received on (b)(6) 2018 from patient.Event verbatim of removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations was updated from removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations.Event outcome for removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations, pain, injected knee swelled up/knee began swelling again, nauseous was updated from unknown to recovered.Corrective treatment was added for infection in my appendix, symptoms were added for same and hospitalization start date was added.Action taken was updated to drug withdrawn.Expiration date was added.Medical history and concomitant medications were added.Clinical course updated.Text amended accordingly.Follow up information was received on 11-sep-2018.No new information received.Additional information received on (b)(6) 2018 from patient.Verbatim of foot of colon had necrosed/gastrointestinal necrosis/necrosed colon was updated.Batch number of suspect was updated.Upon internal review event got removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations was assessed as aesi.Clinical course updated.Text amended accordingly.

Event Description

Infection in my appendix [appendicitis] ([abdominal pain], [fever]) foot of colon had necrosed/gastrointestinal necrosis/necrosed colon [large intestine necrosis] unable to walk [unable to walk] nauseous [nauseous] injected knee swelled up/knee began swelling again [knee swelling] pain [knee pain] removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations [knee effusion] case narrative: this unsolicited case from united states was received on 19-jul-2018 from a patient.This case involves a male patient of unknown age who received treatment with synvisc and later after 16 days injected knee swelled up/knee began swelling again, after 30 days had infection in appendix, foot of colon had necrosed/gastrointestinal necrosis/necrosed colon, was unable to walk, was nauseous, got removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations, had pain, the patient's past medical history included blood triglycerides increased, keratomileusis and arthralgia.The patient's past medical treatment included codeine- itching.The patient's past vaccination(s) and family history were not provided.Concomitant medications included lisinopril (lisinopril) for blood pressure abnormal; and gemfibrozil (gemfibrozil) for blood triglycerides abnormal.On (b)(6) 2018, the patient received treatment with intraarticular synvisc injection (dose, frequency, indication, batch/lot number 7rspo18a and expiry date: sep-2020) into right knee.On (b)(6) 2018, the patient received another synvisc injection (batch/lot number : 7rspo18a).It was reported that the reactions occurred after the patient received the third injection of synvisc on (b)(6) 2018, (batch/lot number: 7rspo18a).On (b)(6) 2018, the patient's injected knee swelled up.On (b)(6) 2018, the patient was unable to walk (local).On the same day , patient had first aspiration.On (b)(6) 2018, patient had another aspiration.On an unknown date in (b)(6) 2018, the patient's doctor removed over 120cc of fluid from his knee and said that would probably be it.The patient's knee began swelling again that night and he drove over an hour each way the next day to have more fluid removed.It was reported that the patient went out of town to visit his son for father's day and could only sit on his lazy boy due to knee swelling.On (b)(6) 2018, the patient went to the emergency room where the doctor against his better judgment removed over 100 cc of fluid again to relieve him of pain.It was reported that the patient spent the next day icing elevating and talking over the counter pain medicines.On(b)(6) 2018, after 24 days, the patient went to work where he was nauseous for the entire week followed by abdominal pain and fever.On an unknown date in 2018, the patient got recovered from nausea, abdominal pain, fever and injected knee swelled up/knee began swelling again.On (b)(6) 2018, in the morning the patient went to the er, they ct scanned and found infection in his appendix and a foot of my colon had necrosed/gastrointestinal necrosis.On the same day, patient had pain and fever.The patient's surgeon went through colon issue with him and told him that it was a mystery in that issue it usually appears in the other side of the colon and the reasons that cause this condition normally tested negative for.The patient told her of his bad experience with the injections, following symptoms and she said it's a possibility this spread to his colon to cause this.As there was no other physical explanation the coincidence and timing could not be overlooked.On (b)(6) 2018, further it was reported that the patient underwent surgery for to remove necrosed colon and appendix where foot of colon and appendix was removed.The patient spent two weeks in the hospital and had been recuperating at home the past two weeks.On the same day, the patient recovered foot of colon had necrosed and infection in my appendix.The patient was hospitalized for a duration of 13 days.Action taken: drug withdrawn.Corrective treatment: fluid removed from knee, had 3 aspirations for injected knee swelled up/knee began swelling again and removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again; fluid removed from knee, icing elevating and talking otc pain medicines for pain; removed appendix for infection in appendix, abdominal surgery and various medication (unspecified); foot of colon had necrosed/gastrointestinal necrosis/necrosed colon; not reported for unable to walk and nauseous outcome: unknown for unable to walk and recovered for all other events.A pharmaceutical technical complaint (ptc) was initiated on (b)(6) 2018, for synvisc with global ptc number: (b)(4).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 monitored adverse event reports with or without lot numbers and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals.This review had not indicated any safety issue.Sanofi will continue to monitor adverse events to determine if a capa is required.Seriousness criteria: hospitalization/prolongation and disability for foot of colon had necrosed/gastrointestinal necrosis/necrosed colon and infection in my appendix additional information was received on 30-jul-2018.Global ptc number and results were added.Text was amended accordingly.Additional information received on 01-aug-2018 from patient.Product lot number added with injection details.Event details and outcome updated for foot of colon had necrosed and infection in my appendix.Verbatim updated for removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations to removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again.Seriousness criterion of disability added.Clinical course updated.Text amended accordingly.Additional information was received on 20-aug-2018 from patient.Event verbatim of removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations was updated from removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations.Event outcome for removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 3 aspirations, pain, injected knee swelled up/knee began swelling again, nauseous was updated from unknown to recovered.Corrective treatment was added for infection in my appendix, symptoms were added for same and hospitalization start date was added.Action taken was updated to drug withdrawn.Expiration date was added.Medical history and concomitant medications were added.Clinical course updated.Text amended accordingly.Follow up information was received on 11-sep-2018.No new information received.Additional information received on 17-oct-2018 from patient.Verbatim of foot of colon had necrosed/gastrointestinal necrosis/necrosed colon was updated.Batch number of suspect was updated.Upon internal review event got removed over 120cc of fluid/drove over an hour each way the next day to have more fluid removed/removed over 100 cc of fluid again/had 2 aspirations was assessed as aesi.Clinical course updated.Text amended accordingly additional information received on 25-oct-2018 from patient.Clinical course was updated and text amended accordingly.

• Brand Name: SYNVISC
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• MDR Report Key: 7949298
• MDR Text Key: 123198030
• Report Number: 2246315-2018-00658
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 7RSPO18A
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GEMFIBROZIL (GEMFIBROZIL),; GEMFIBROZIL (GEMFIBROZIL),; GEMFIBROZIL (GEMFIBROZIL),UNKNOWN; LISINOPRIL (LISINOPRIL),; LISINOPRIL (LISINOPRIL),; LISINOPRIL (LISINOPRIL),UNKNOWN
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 61 YR
• Patient Weight: 250