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

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

Patient Problems Stroke/CVA (1770); Paralysis (1997); No Code Available (3191)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Stroke; paralyzed on his right side (right sided paralysis); nonverbal (speech loss); injured being on duty and the reason for getting synvisc-one injections (device use in unapproved indication).Case narrative: this case is cross referenced with case id.: (b)(4) (multiple devices) and (b)(4) (cluster case).Initial information received on (b)(4) 2019 from united states regarding an unsolicited valid serious case received from patient's wife.This case involves a (b)(6) years old male patient who experienced stroke, completely paralyzed on his right side, nonverbal and injured/reason for him getting synvisc-one injections, while he using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown).The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had received prior injection of synvisc one ((b)(6) 2017) and never has stroke prior to synvisc one.On (b)(6) 2018, the patient received hylan g-f 20, sodium hyaluronate intra-articular injection at dosage of 6 ml for once only in 6 months unknown (lot - unk) for injury.It was also reported that he was injured on duty and was given synvisc one injections.On the unknown date in (b)(6) 2018, after six weeks of administration of injection, patient developed stroke.It was also reported that the patient was completely paralyzed on his right side and nonverbal.Final diagnosis was injured/reason for him getting synvisc-one injections, nonverbal, completely paralyzed on his right side and stroke.Corrective treatment: not reported for all the events.Outcome: unknown for rest of the events except injured/reason for him getting synvisc-one injections.Seriousness criteria: medically significant for stroke and completely paralyzed on his right side.A product technical complaint was initiated, and results were pending for same.

Event Description

Stroke [stroke].Paralyzed on his right side [right sided paralysis].Nonverbal [speech loss].Injured being on duty and the reason for getting synvisc-one injections [device use in unapproved indication].Case narrative: this case is cross referenced with case id.: (b)(4),initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from patient's wife.This case involves a 35 years old male patient who experienced stroke, completely paralyzed on his right side, nonverbal and injured/reason for him getting synvisc-one injections, while he using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown) the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had received prior injection of synvisc one (b)(6) 2017 and never has stroke prior to synvisc one.On (b)(6) 2018, the patient received hylan g-f 20, sodium hyaluronate intra-articular injection at dosage of 6 ml for once only in 6 months unknown (lot - unk) for injury.It was also reported that he was injured on duty and was given synvisc one injections.On the unknown date in (b)(6) 2018, after six weeks of administration of injection, patient developed stroke.It was also reported that the patient was completely paralyzed on his right side and nonverbal.Final diagnosis was injured/reason for him getting synvisc-one injections, nonverbal, completely paralyzed on his right side and stroke.Corrective treatment: not reported for all the events.Outcome: unknown for rest of the events except injured/reason for him getting synvisc-one injections.Seriousness criteria: medically significant for stroke and completely paralyzed on his right side.A product technical complaint was initiated on (b)(6) 2019 for synvisc one (lot number unknown) with 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 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 adverse events to determine if a capa is required.Additional information was received on 20-mar-2019.Ptc results received and processed.Global ptc number added.

Event Description

Stroke [stroke].Paralyzed on his right side [right sided paralysis].Nonverbal [speech loss].Injured being on duty and the reason for getting synvisc-one injections [product use in unapproved indication].Case narrative: this case is cross referenced with case id.: (b)(4).Initial information received on 12-mar-2019 from united states regarding an unsolicited valid serious case received from patient's wife.This case involves a 35 years old male patient who experienced stroke, completely paralyzed on his right side, nonverbal and injured/reason for him getting synvisc-one injections, while he using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).(latency: unknown) the patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.The patient had received prior injection of synvisc one (05-aug-2017) and never has stroke prior to synvisc one.On 12-feb-2018, the patient received hylan g-f 20, sodium hyaluronate intra-articular injection at dosage of 6 ml for once only in 6 months unknown (lot - unk) for injury.It was also reported that he was injured on duty and was given synvisc one injections.On the unknown date in mar-2018, after six weeks of administration of injection, patient developed stroke.It was also reported that the patient was completely paralyzed on his right side and nonverbal.Final diagnosis was injured/reason for him getting synvisc-one injections, nonverbal, completely paralyzed on his right side and stroke.Corrective treatment: not reported for all the events.Outcome: unknown for rest of the events except injured/reason for him getting synvisc-one injections.Seriousness criteria: medically significant for stroke and completely paralyzed on his right side.A product technical complaint was initiated on (b)(6) 2019 for synvisc one (lot number unknown) with 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 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 adverse events to determine if a capa is required.Additional information was received on 20-mar-2019.Ptc results received and processed.Global ptc number added.Follow up information received on 03-may-2019 from consumer.No new information.Upon internal review on (b)(6) 2019 with the clock start date of (b)(6) 2019, the event coding was updated from device use issue to product use in unapproved indication.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 8431843
• MDR Text Key: 139178167
• Report Number: 2246315-2019-00090
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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
• Patient Age: 35 YR