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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Joint Swelling (2356)

Event Date 11/01/2014

Event Type  Injury  

Event Description

This unsolicited device case from (b)(6) was received on (b)(6) 2014 from a physician.This case is cross reference to case id: (b)(4) and (b)(4) (same reporter, cluster).This case concerns a (b)(6) male pt who had effusion nos after receiving treatment with synvisc.The pt's medical history was significant for use of synvisc (2 sessions).No relevant past drugs, concomitant medications and concurrent conditions were reported.On an unk date in (b)(6) 2014, the pt received treatment with synvisc injection at a dose of 2 ml, once (third session) (route of administration, indication, lot/batch number and exp date; not reported) into an unspecified joint.On an unk date in (b)(6) 2014, about one week later, the pt was presented with an effusion.It was reported that the pt's physician did not manage to perform a puncture and prescribed an unspecified anti-inflammatory drug.On a unk date, a sometime later, the pt went to see his rheumatologist who performed a puncture (unk amount aspirated) and results a puncture (unk amount aspirated) and results showed that the liquid was free of germs.The rheumatologist prescribed an oral unspecified corticoid drug to the pt.On an unk date, the pt recovered from the event.Action taken: stopped temporarily.Outcome: recovered/resolved.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.Seriousness criteria: required intervention (administered oral unspecified corticoid drug).French imputability number: (b)(4).

• Brand Name: SYNVISC (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY; ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corp dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4369867
• MDR Text Key: 16303188
• Report Number: 2246315-2014-75391
• 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
• Report Date: 12/17/2014

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
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 12/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CON MEDS = UNK; SYNVISC (PREV)
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR