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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cellulitis (1768)

Event Type  Injury  

Event Description

This solicited device case from (b)(6) was received on 10/22/2014 from the patient via patient support program.This case involves a male patient (age not provided) who developed cellulitis in the left leg and complained that treatment with synvisc one injection didn't work (sub therapeutic response).No medical history, past drugs, concomitant medications and concurrent conditions were reported.On an unknown date, the patient received treatment with synvisc one injection, at a dose of 06 ml, once, (indication, batch/lot number and expiry date: not reported) into both knees.It was reported that the injection worked well in one knee (right knee) while it didn't work as well (sub therapeutic response) in the other knee (left knee) but the patient was walking straighter.Reportedly, the patient had a problem of cellulitis in the left leg which was believed to have started after administration of synvisc one (date and latency unknown).Corrective treatment: not reported.Outcome: not recovered/not resolved for the event of cellulitis in the left leg.A pharmaceutical technical complaint (ptc) was initiated with (b)(4) and results were pending for the same.Company causality: associated.Seriousness criteria: important medical event for the event of cellulitis in the left leg.No further information was provided.Consent to contact doctor for follow up was denied.

Manufacturer Narrative

Pharmacovigilance comment: sanofi company comment dated 10/28/2014: based on information received the role of synvisc one cannot be excluded for the event of cellulitis in the left leg.However, lack of information regarding patient's medical history and concomitant medications precludes comprehensive case assessment.

• Brand Name: SYNVISC ONE (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., ms 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4218684
• MDR Text Key: 4975538
• Report Number: 2246315-2014-46005
• 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,Study,Consumer
• Type of Report: Initial
• Report Date: 10/22/2014

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: 10/22/2014
• Initial Date FDA Received: 10/28/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PREV MEDS - UNKNOWN; CON MEDS - UNKNOWN
• Patient Outcome(s): Other