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

Lot Number 6RSL050

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

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

This unsolicited case from united states was received on 29-mar-2018 from a other health care professional.This case concerns a male patient (age not provided) who received treatment with synvisc one injection and after unknown latency had recurrent effusion afterwards and was positive for e coli.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (dose, frequency and indication: not provided and batch/lot number: 6rsl050).On an unknown date, after unknown latency, patient had recurrent effusion afterwards and was positive for e coli.Physician was wondering if there was testing done on lot 6rsl050 which was injected into patient's knee.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event.Pharmacovigilance comment: sanofi company comment dated (b)(6) 2018.This case concerns a patient who presented arthritis bacterial after receiving treatment with synvisc one.Based upon the information, the causal role of the product cannot be denied with the occurrence of event.However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better assessment of the case.

Event Description

This unsolicited case from united states was received on 29-mar-2018 from a other health care professional.This case concerns a male patient (age not provided) who received treatment with synvisc one injection and after unknown latency had recurrent effusion afterwards and was positive for e coli.No medical history, past drug, concomitant medication and concurrent condition was provided.On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (dose, frequency and indication: not provided and batch/lot number: 6rsl050).On an unknown date, after unknown latency, patient had recurrent effusion afterwards and was positive for e coli.Physician was wondering if there was testing done on lot 6rsl050 which was injected into patient's knee.Corrective treatment: not reported.Outcome: unknown.Seriousness criteria: important medical event.A product technical complaint was initiated with gptc number: (b)(4).The production and quality control documentation for lot # 6rsl050 expiration date (2019-10-31) was reviewed.The investigation showed that the product met specifications.No associated non-conformance were noted.Based on the lot # batch record review & lot # frequency analysis for lot # 6rsl050 no capa was 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 11-apr-18, there were (b)(4) complaints on file for lot # 6rsl050: (1) detached leur-lok hub, (3) adverse event reports, (1) loose luer-lok hub (2 syringes), (1) leaky syringe and (1) broken luer-lok hub.Sanofi would continue to monitor complaints as stated in sop (b)(4)? product complaint handling? to determine if a capa was required.Additional information was received on 11-apr-2018.Investigation summary and gptc number was added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated 11-apr-18.Follow up information received does not change previous case assessment.This case concerns a patient who presented arthritis bacterial after receiving treatment with synvisc one.Based upon the information, the causal role of the product cannot be denied with the occurrence of event.However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better assessment of the case.

• 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: 7446089
• MDR Text Key: 106010640
• Report Number: 2246315-2018-00449
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: 6RSL050
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other