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

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

Patient Problem Cellulitis (1768)

Event Type  Injury  

Event Description

This unsolicited case from united states was received on (b)(6) 2017 from a healthcare professional (physicians assistant).This case concerns a female patient of unknown age who received treatment with synvisc one and after unknown latency had contracted cellulitis.No medical history, past drugs, concomitant medication or concurrent condition was reported.On an unknown date, the patient received treatment with intra-articular synvisc one injection (dose, frequency and indication: not reported) into unspecified location.On an unknown date, after unknown latency, the patient was said to have contracted cellulitis.The patient was said to need between 3 and 6 days of hospitalization, and received intravenous (i.V.) antibiotics through a peripherally inserted central catheter (picc) line.No time-frame was provided to the occurrence of the injection, or the follow-up hospitalization.Corrective treatment: iv antibiotics.Outcome: unknown.Seriousness criterion: hospitalization a pharmaceutical technical complaint (ptc) was initiated 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 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 had not indicated any safety issue.Sanofi would continue to monitor adverse events to determine if a capa was required.Additional information was received on (b)(6) 2018.Global ptc number and ptc results added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment follow up dated (b)(6) 2018: the follow-up received does not change the previous assessment of the case.This case concerns a patient who received treatment with synvisc one injection and later experienced to have cellulitis.Based on the available information, temporal relationship cannot be established between the event and the suspect product.However, information regarding latency, injected lot number, injection technique used, past drugs, concomitant medications and other risk factors is required for further 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
• Manufacturer Contact: heather schiappacasse ; 55 corporate drive; 55b-220a; bridgewater, NJ 08807 ; 9089817289
• MDR Report Key: 7217979
• MDR Text Key: 98167280
• Report Number: 2246315-2018-00138
• 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
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization