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

Lot Number S13061

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Event Description

This solicited device case was received on (b)(6) 2014 from a patient via (b)(6).Patient id: (b)(6).Study title: (b)(6).No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported.On (b)(6) 2014, the patient initiated treatment with synvisc one injection, at a dose of 6 ml once (route and expiration date not provided and batch/lot number: s13061) for osteoarthritis.On unknown date, the patient died due to unspecified reason.It was unknown if an autopsy was performed.Corrective treatment: no corrective treatment was provided.A pharmaceutical technical complaint (ptc) was initiated and conclusion was pending for the same.Reporter's causality assessment: not reported.Company causality assessment: associated.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated (b)(6) 2014: this is an initial case concerning (b)(6) male patient who died after receiving treatment with synvisc one for osteoarthritis.Since the date of death is unknown therefore the causal role of synvisc one cannot be completely excluded for the event.However the lack of information regarding the underlying medical history, concomitant medications used by the patient, autopsy findings and the further information lack regarding the autopsy details precludes the complete case assessment.

• Brand Name: SYNVISC ONE (SYNVISC ONE)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corp. dr.; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4359655
• MDR Text Key: 5116089
• Report Number: 2246315-2014-70484
• 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,Study,Consumer
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: S13061
• Initial Date Manufacturer Received: 12/08/2014
• Initial Date FDA Received: 12/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS = UNK; PREV MEDS = UNK
• Patient Outcome(s): Death
• Patient Age: 64 YR