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

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  No Answer Provided  

Event Description

This unsolicited device case from united states was received on (b)(4) 2014 from a consumer (patient's sister).This case concerns a (b)(6) male patient who died whilst receiving treatment with synvisc.No past drugs, medical history, concomitant medications or concurrent condition was reported.On an unknown date in (b)(6) 2012, the patient initiated treatment with 2 ml, synvisc injection (route, frequency, indication, batch/lot number and expiration date: not provided) into unspecified knee.On an unknown date in (b)(6) 2013, the patient received synvisc injection.On an unknown date, the patient died due to unspecified cause.It was unknown whether an autopsy was done.A global pharmaceutical technical complaint (ptc) was initiated and ptc results were pending for the same.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated (b)(4) 2014: this is an initial case concerning a (b)(6) male patient who passed away while on synvisc therapy.The unknown cause of death, lack of information regarding temporal relationship, patient's underlying concurrent medical conditions and concomitant medications precludes the complete medical assessment of the case.

• Brand Name: SYNVISC
• 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: 4370045
• MDR Text Key: 5263127
• Report Number: 2246315-2014-77870
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2014

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: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 12/24/2014
• 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: 80 YR