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

Lot Number UNKNOWN

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

Patient Problems Bacterial Infection (1735); No Code Available (3191)

Event Type  Injury  

Event Description

This sponsored solicited case from united states was received on 25-jan-2017 from a physician via market research.(b)(4).This case involves a patient of unspecified demographics who was hospitalized (latency: unknown) because of synvisc one and after unknown latency got c.Diff.Colitis.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unknown date, the patient initiated treatment with synvisc one injection (dose, frequency, indication, route, batch/ lot number and expiration date: not provided) into an unspecified location.On an unknown date, after unknown latency, the patient was hospitalized because of synvisc one.On an unknown date, after unknown latency, the patient got antibiotics and got c.Diff.Colitis after that.Action taken: unknown.Corrective treatment: not reported for both the events.Outcome: unknown for both the events a pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Reporter causality: associated (related) for both the events company causality: associated for patient hospitalized because of synvisc one; not associated for c.Diff.Colitis seriousness criteria: important medical event (ime) for c.Diff.Colitis pharmacovigilance comment: sanofi company comment dated 31-jan-2017: this case concerns a patient who was reported to have been hospitalized due to synvisc one (reason not specified) and received antibiotics after which developed clostridium difficile colitis.The causal role of synvisc one in the occurrence of c.Diff.Colitis cannot be established as there is no evidence to suggest a positive causal role.Patient's hospitalization and administration of unspecified antibiotics acts as confounding factors in causality assessment.However, information regarding exact cause of hospitalization, clinical course and lab data will aid in comprehensive assessment of this case.

Event Description

This sponsored solicited case from united states was received on 25-jan-2017 from a physician via market research.Study title: visco supplement decision maker and buying process evaluation proposal this case involves a patient of unspecified demographics who was hospitalized (latency: unknown) because of synvisc one and after unknown latency got c.Diff.Colitis.No past drugs, medical history, concomitant medication or concurrent condition was reported.On an unknown date, the patient initiated treatment with synvisc one injection (dose, frequency, indication, route, batch/ lot number and expiration date: not provided) into an unspecified location.On an unknown date, after unknown latency, the patient was hospitalized because of synvisc one.On an unknown date, after unknown latency, the patient got antibiotics and got c.Diff.Colitis after that.Action taken: unknown corrective treatment: not reported for both the events outcome: unknown for both the events a pharmaceutical technical complaint (ptc) was initiated with (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 monitored adverse event reports with or without lot numbers, and assessed 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 will continue to monitor adverse events to determine if a capa is required.Reporter causality: associated (related) for both the events company causality: associated for patient hospitalized because of synvisc one; not associated for c.Diff.Colitis seriousness criteria: important medical event (ime) for c.Diff.Colitis additional information was received on 07-feb-2017.Global ptc number and results were added.Text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 7-feb-2017: the follow up information received does not change previous case assessment.Sanofi company comment dated 31-jan-2017: this case concerns a patient who was reported to have been hospitalized due to synvisc one (reason not specified) and received antibiotics after which developed clostridium difficile colitis.The causal role of synvisc one in the occurrence of c.Diff.Colitis cannot be established as there is no evidence to suggest a positive causal role.Patient's hospitalization and administration of unspecified antibiotics acts as confounding factors in causality assessment.However, information regarding exact cause of hospitalization, clinical course and lab data will aid in comprehensive assessment of this case.

• 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: 6310174
• MDR Text Key: 66763373
• Report Number: 2246315-2017-00015
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P940015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• 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; Other