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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Pain (1994)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2014 from a non-healthcare professional.This case concerns a (b)(6) year old female patient whose pain returned after receiving treatment with synvisc-one.The patient's medical history included knee pain.No past drug, concomitant medication and concurrent condition was reported.On an unknown date in (b)(6) 2014, the patient initiated treatment with synvisc one injection (route of administration, indication, dosage regimen, frequency, lot/ batch number and expiration date unknown) in both knees.It was reported that the patient had positive results, on an unknown date, after an unknown latency, the patient's pain returned and it was reported that the pain returned 2 weeks ago.Action taken: unknown.Corrective treatment: cortisone injection.Outcome: unknown.A pharmaceutical technical complaint (ptc) was initiated and results were pending for the same.No further information was provided.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4360203
• MDR Text Key: 15320226
• Report Number: 2246315-2014-74103
• 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: 12/12/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 12/19/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR