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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

This unsolicited device case was received from (b)(6) on (b)(6) 2014 from a patient.This case concerns a female patient of unknown age who experienced allergic shock after receiving treatment with synvisc injection.No medical history, past drugs, other concomitant medication or concurrent conditions were reported.On an unspecified date, the patient started treatment with intraarticular synvisc injection (dose, frequency, indication, batch/lot number and expiration date: not provided).Later, after unknown latency, patient reacted to adminstration of synvisc into knee with allergic shock.It was reported that admission to hospital was required.Treatment with synvisc was discontinued.Action taken: drug withdrawn; corrective treatment: not reported; outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and conclusion was pending for the same.Seriousness assessment: inpatient/prolonged hospitalization.

• Brand Name: SYNVISC (SYNVISC)
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY; ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive, ms 55c-235a; ridgefield, NJ 07657-2397 ; 9089812784
• MDR Report Key: 4379989
• MDR Text Key: 20977241
• Report Number: 2246315-2014-76599
• 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,Consumer
• Type of Report: Initial
• Report Date: 12/18/2014

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: 12/18/2014
• Initial Date FDA Received: 12/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PREV MEDS - UNK; CON MEDS - UNK
• Patient Outcome(s): Hospitalization