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

Device Problem Insufficient Information (3190)

Patient Problems Swelling (2091); Alteration In Body Temperature (2682)

Event Type  Injury  

Event Description

This unsolicited device case was received from united states on (b)(6) 2014 from a nurse via a sales representative.This case concerns a (b)(6) female patient whose knee was swollen and warm after receiving treatment with synvisc injection.No relevant medical history, past drugs, concomitant medication or concurrent conditions was reported.On an unknown date, the patient initiated treatment with synvisc injection (route, dosage regiment, batch/lot number and expiration date unknown) into an unspecified knee for an unknown indication.On an unknown date, on a monday, the patient received second synvisc injection into an unspecified knee.The next day, on tuesday, the patient's knee was swollen and warm.It was reported that the patient was prescribed prednisone for the events and a couple of days later, the patient was fine.Action taken: unknown.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: 55 corporate dr; mail stop: 55d-205a; bridgewater, NJ 08807 ; 9089816698
• MDR Report Key: 3624670
• MDR Text Key: 4204842
• Report Number: 2246315-2014-13338
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2014
• 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): Required Intervention
• Patient Age: 43 YR