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

Lot Number 4RSD007

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Swelling (2091); Alteration In Body Temperature (2682)

Event Type  Injury  

Event Description

This unsolicited device case from united states was received on (b)(6) 2015 from a healthcare professional (other).This case was cross with cases: (b)(4) and (b)(4) (cluster cases).This case concerns a (b)(6) year old male pt who experienced large, hot and red knee while receiving treatment with synvisc.The pt had received several series of synvisc in the past.No medical history, concomitant medication or concurrent condition was reported.On an unk date, the pt initiated treatment with intra-articular synvisc injection at a dose of 2 ml (frequency and expiration date: not provided; batch/lot number 4rsd007) for osteoarthritis.On an unk date, the pt went to the emergency room (er) and the knee was washed out.It was reported that the lab culture was negative.Corrective treatment: knee arthroscopy for large knee; not reported for other two events.Outcome: unk for all the events.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Seriousness criteria: required intervention for large knee.

• Brand Name: SYNVISC
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4837701
• MDR Text Key: 5904195
• Report Number: 2246315-2015-79677
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 4RSD007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/03/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNVISC (PREV.); CON MEDS
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR