MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; INTRA-ARTICULAR HYALURONIC ACID

Lot Number 7RSL007

Device Problem Loss of Data (2903)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

This case has been cross referred with case (b)(4) (cluster) this unsolicited case from united states was received on 02-mar-2018 from a physician's assistant.This case concerns a (b)(6) years old male patient who received treatment with synvisc one injection and developed infection (after unknown latency).No medical history, past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2018, patient received treatment with intraarticular synvisc one injection (dose, frequency and indication unknown) (batch/lot number: 7rsl007; expiration date: mar-2020) in his knee.On an unknown date, after unknown latency, the patient developed infection and had to be hospitalized.It was reported that the patient was still in hospital.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A global pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: in patient or prolonged hospitalization for the event of infection pharmacovigilance comment: sanofi company comment dated 08-mar-2018: this case concerns a patient who received treatment with synvisc one for an unknown indication.Later, on an unknown date, patient experienced event of infection and was hospitalized due to the same.Since the event occurred after receiving treatment with the suspect product, the causal role of suspect in the occurrence of the event cannot be denied.However, lack of information regarding the lot number, patient's medical history, concomitant medication and other details precludes complete case assessment.

Event Description

This case has been cross referred with case (b)(4).This unsolicited case from united states was received on (b)(6) 2018 from a physician's assistant this case concerns a 63 years old male patient who received treatment with synvisc one injection and developed infection (after unknown latency).No medical history, past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2018, patient received treatment with intraarticular synvisc one injection (dose, frequency and indication unknown) (batch/lot number: 7rsl007; expiration date: mar-2020) in his knee.On an unknown date, after unknown latency, the patient developed infection and had to be hospitalized.It was reported that the patient was still in hospital.Action taken: unknown.Corrective treatment: not reported.Outcome: unknown.A global pharmaceutical technical complaint (ptc) was initiated with global ptc number (b)(4).The production and quality control documentation for lot # 7rsl007 expiration date (2020-03-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformances were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 7rsl007 no capa is required.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.As of (b)(6) 2018 there are 8 complaints on file for lot # 7rsl007: (1) defective syringe, (1) tip breakage, (1) broken luer lok hub, (1) leaky syringe and (4) pre-adverse events.Sanofi will continue to monitor complaints as stated in (b)(4) product complaint handling to determine if a capa is required.Seriousness criteria: in patient or prolonged hospitalization for the event of infection additional information was received on 24-apr-2018.Global ptc number and results were added.Pharmacovigilance comment: sanofi company comment dated 24-apr-2018: the follow up information received does not change previous case assessment.This case concerns a patient who received treatment with synvisc one for an unknown indication.Later, on an unknown date, patient experienced event of infection and was hospitalized due to the same.Since the event occurred after receiving treatment with the suspect product, the causal role of suspect in the occurrence of the event cannot be denied.However, lack of information regarding the lot number, patient's medical history, concomitant medication and other details precludes complete case assessment.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleadantview terrace; ridgefield NJ 07657
• MDR Report Key: 7340674
• MDR Text Key: 102440077
• Report Number: 2246315-2018-00392
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: Health Professional
• Device Expiration Date: 03/01/2020
• Device Lot Number: 7RSL007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/03/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR