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

Lot Number P1403

Device Problems Difficult to Insert (1316); Product Quality Problem (1506)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Ambulation Difficulties (2544); Alteration In Body Temperature (2682)

Event Date 11/01/2014

Event Type  Injury  

Event Description

This unsolicited device case from the u.S.Was received on 11/26/2014 from a non-healthcare professional.This case involves (b)(6) year old female patient who had pain, swelling, redness, experienced heat and was limping after receiving treatment with synvisc one.The patient had received synvisc one to right knee previously that worked beautifully.No medical history, concomitant medication or concurrent condition was reported.On (b)(6) 2014, the patient commenced treatment with synvisc one injection at a dose of 6 ml once (route: not provided; batch/lot number: p1403; expiration date: 02/28/2017) into left knee for osteoarthritis.It was reported that it seemed like the synvisc one was thicker than it usually is and it was hard to get in it.On an unk date in (b)(6) 2014, the patient came back 2 days later with pain, swelling, redness and heat.It was reported that an attempt was made to withdraw effusion but nothing came out and the patient was administered a steroid injection for the events.It was reported that the swelling went down but the pain continued for 4-5 days.It was further reported that the patient was no longer limping.Corrective treatment: no treatment for limping and steroid injection for rest of the events.Outcome: recovered for all the events.Seriousness criteria: required intervention for pain, swelling, redness and heat.A pharmaceutical tech complaint (ptc) was initiated and ptc results were pending.

Manufacturer Narrative

Sanofi company comment dated 12/02/2014: this case concerns (b)(6) year old female patient who experienced pain, redness, swelling and heat after receiving synvisc one in her left knee for osteoarthritis.Since the patient started experiencing the events within a significant temporal gap of receiving synvisc one, so the causal role of suspect could not be ruled out.However, the lack of info regarding the concomitant medications used by the patient, any past medical drugs makes it difficult to assess the definitive etiology for the 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: 4307939
• MDR Text Key: 5134146
• Report Number: 2246315-2014-65072
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Lot Number: P1403
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNVISC ONE (PREV.): CON MEDS, UNK, UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR