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

Lot Number UNKNOWN

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Event Description

This unsolicited case from (b)(6) was received on 04-aug-2016 from a physician.This case concerns a male patient of unknown age who received treatment with synvisc and later after unknown latency experienced anaphylactic shock.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient received treatment with intra-articular synvisc injection (dose, frequency, indication, batch/lot number and expiration.Date: not provided).On an unknown date, after unknown latency, the patient experienced anaphylactic shock within the use of synvisc.Action taken: unknown.Corrective treatment: unknown.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: important medical event (ime).Pharmacovigilance comment: sanofi company comment dated 8-aug-2016: this case concerns a patient who experienced anaphylactic shock after receiving synvisc injection.The report contains no information regarding temporal relationship and the clinical course of the patient; hence, there is limited evidence to support a causal relationship.However, based upon the nature of the event the causal role of the product cannot be denied.Further information is required to make a comprehensive case assessment.

Event Description

This unsolicited case from (b)(6) was received on 04- aug-2016 from a physician.This case concerns a male patient of unknown age who received treatment synvisc and later after unknown latency experienced anaphylactic shock.No past drug, medical history, concomitant medication or concurrent condition was provided.On an unknown date, the patient received treatment with intra-articular synvisc injection (dose, frequency, indication, batch/lot number and expiration date: not provided).On an unknown date, after unknown latency, the patient experienced anaphylactic shock within the use of synvisc.Action taken: unknown.Corrective treatment: unknown.Outcome: unknown.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 genzyme 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 genzyme biosurgery would continue to monitor adverse events to determine if a capa was required seriousness criteria: important medical event (ime).Additional information was received on 16-aug-2016: global ptc number and ptc results were added.Pharmacovigilance comment: sanofi company comment follow up dated 16-aug-2016: the follow up information received does not change previous case assessment.Sanofi company comment dated 8-aug-2016: this case concerns a patient who experienced anaphylactic shock after receiving synvisc injection.The report contains no information regarding temporal relationship and the clinical course of the patient; hence, there is limited evidence to support a causal relationship.However, based upon the nature of the event the causal role of the product cannot be denied.Further information is required to make a comprehensive case assessment.

• Brand Name: SYNVISC (SYNVISC)
• 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: 5869338
• MDR Text Key: 51875142
• Report Number: 2246315-2016-00122
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2016
• 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): Other