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

Lot Number V1212A1

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Swelling (2091); Alteration In Body Temperature (2682); Fluid Discharge (2686)

Event Date 04/29/2015

Event Type  Injury  

Event Description

This solicited device case from united states was rec'd on (b)(6) 2015 (initial information rec'd on (b)(6) 2015, both the information processed together with clock start date of (b)(6) 2015) from a healthcare professional (physician's assistant) via patient support program.This case was cross referenced with cases: (b)(4) (cluster).Study title: unsponsored study involving synvisc one.This case involves a (b)(4) female patient who rec'd treatment with synvisc one and complained of swollen, hot, painful knee and excess fluid in the knee.On (b)(6) -2014, the patient rec'd treatment with synvisc one.No medical history, concomitant medication or concurrent condition was reported.On (b)(6) 2015, the patient rec'd treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: v1212a1; expiration date: aug-2015) into an unspecified knee for knee osteoarthritis.On (b)(6) 2015, 09 days after the synvisc one injection, the patient experienced swollen, hot, painful knee.There was no fever and no evidence of sepsis.It was reported that excess fluid from the knee was removed and the patient received oral steroids, intra-muscular ketorolac tromethamine (toradol) and non-steroidal anti-inflammatory drugs (nsaids) as treatment for the events.It was further reported that the patient responded well to steroids and ketorolac tromethamine.On unk dates, the patient recovered from swollen, hot, painful knee.Outcome: unk for excess fluid in the knee.A pharmaceutical technical complaint (ptc) was initiated and ptc results were pending.Reporter casualty: not reported for all events.Company casualty: associated for all events.Seriousness criteria: required intervention for all events.

• 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 dr; mail stop: 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4908227
• MDR Text Key: 6031464
• Report Number: 2246315-2015-97415
• 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: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2015
• Device Lot Number: V1212A1
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNVISC ONE (PREV.); CON MEDS = UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 116