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

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

Patient Problem Sepsis (2067)

Event Type  Injury  

Event Description

Asepsis [sepsis]: case narrative: initial information received on 06-feb-2020 from united states regarding an unsolicited valid serious case received from a physician.This case involves a patient who experienced asepsis, with the use of medical device 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.On an unknown date, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), (formulation, dosage, route, lot, indication for unknown).On an unknown date, the patient experienced asepsis, after use of hylan g-f 20 and sodium hyaluronate.This event was assessed as medically significant.Action taken- not applicable.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for asepsis.A product technical complaint was initiated and results were pending for the same.

Event Description

Pseudosepsis [pseudosepsis].Case narrative: upon internal review on 14-apr-2020, the case initially assessed as serious was updated to non-serious (medically significant seriousness criteria removed for pseudosepsis).Initial information received on 06-feb-2020 from united states regarding an unsolicited valid non-serious case from a physician.This case involves a patient (unknown demographics) who experienced pseudosepsis, with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one).The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.On an unknown date, the patient started using synvisc one (hylan g-f 20, sodium hyaluronate), (formulation, dosage, route, lot, indication: unknown).Information on lot number was requested.On an unknown date, after unknown latency, after use of hylan g-f 20 and sodium hyaluronate, the patient experienced pseudosepsis.Action taken- not applicable.It was not reported if the patient received a corrective treatment.The patient outcome is reported as unknown for pseudosepsis.A product technical complaint was initiated on 07-feb-2020 for synvisc one, batch number: unknown; gptc number 100021740 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 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.Final investigation was completed on 14-apr-2020.Follow up information received on 07-feb-2020.No new information.Additional information was received on 14-apr-2020 from other healthcare professional: ptc results were received and added to the case.Upon internal review, the event term was updated from sepsis to pseudosepsis.Case updated from serious to non-serious consequently.Text amended accordingly.Local comments: *downgrade*.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME CORPORATION(RIDGEFIELD); 1125 pleasantview terrace; ridgefield 07657
• MDR Report Key: 9721156
• MDR Text Key: 192461809
• Report Number: 2246315-2020-00037
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• 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