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 Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 01/01/2015

Event Type  Injury  

Event Description

This case is cross referenced with case: (b)(4).This unsolicited device case from united states was received on 17-dec-2015 from a nurse.This case concerns a male patient of unknown age who experienced cellulitis infection and staph infection after receiving treatment with synvisc one.No past drug, medical history or concurrent condition was provided.The patient's concomitant medications included triamcinolone acetonide (kenalog) and lidocaine (from multi dose vials).On an unknown date in (b)(6) 2015, the patient initiated treatment with intra-articular synvisc one injection once (dose, indication, batch/lot number and expiration date: not provided).On unknown dates, within the few days of injection the patient developed cellulitis infection and staph infection.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.Seriousness criteria: important medical event (ime) for both the events.Pharmacovigilance comment: sanofi company comment dated 21-dec-2015: this case concerns a patient who received injection of synvisc one and experienced staphylococcal infection and cellulitis.The causal role of the product in the occurrence of the event cannot be denied completely, however, there is no information regarding the site of infection and the nature of event.Also, lack of information regarding concurrent condition and risk factors precludes a comprehensive assessment of this case.

Event Description

This case is cross referenced with case: (b)(4) (cluster).This unsolicited device case from united states was received on 17-dec-2015 from a nurse.This case concerns a male patient of unknown age who experienced cellulitis infection and staph infection after receiving treatment with synvisc one.No past drug, medical history or concurrent condition was provided.The patient's concomitant medications included triamcinolone acetonide (kenalog) and lidocaine (from multi dose vials).On an unknown date in (b)(6) 2015, the patient initiated treatment with intra-articular synvisc one injection once (dose, indication,batch/lot number and expiration date: not provided).On unknown dates, within the few days of injection the patient developed cellulitis infection and staph infection.Corrective treatment: not reported for both the events.Outcome: unknown for both the events.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.Genzyme 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.Genzyme biosurgery would continue to monitor adverse events to determine if a capa was required.Seriousness criteria: important medical event (ime) for both the events.Additional information was received on 22-dec-2015.Ptc results were added and the text was amended accordingly.Pharmacovigilance comment: sanofi company comment for follow up dated 22-dec-2015: the follow up information does not change the prior case assessment.Sanofi company comment dated 21-dec-2015: this case concerns a patient who received injection of synvisc one and experienced staphylococcal infection and cellulitis.The causal role of the product in the occurrence of the event cannot be denied completely, however, there is no information regarding the site of infection and the nature of event.Also, lack of information regarding concurrent condition and risk factors precludes a 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: kristen sharma ; 55 corporate drive; 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 5339817
• MDR Text Key: 34882545
• Report Number: 2246315-2015-98623
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2016
• 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 the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• 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
• Treatment: LIDOCAINE(CON.)
• Patient Outcome(s): Other