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

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Markings/Labelling Problem (2911)

Patient Problems Hypoglycemia (1912); Pain (1994); Swelling (2091); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

This solicited device case was received on (b)(4) 2014 from a pt via a pt support program.This case was cross referenced with case id (b)(6) (same pt).Pt id: unk.Country: united states.Study title: pt support program involving synvisc one.This case concerns a (b)(6) male pt who had surgeries, surgery on elbow and finger, blood sugar goes from 500 mg/dl and last week down to 32 mg/ml, his glycosylated haemoglobin (hba1c) was 8.1% and has decreased to 7.8%, disturbs his sleep, injections are painful, knee swells to 2.5 times its size whilst receiving treatment with synvisc one injection.The pt's med history included accident at work and was on disability.It was reported that the pt had 7 surgeries in the past 8-9 years with the most in the last 3 years.No past drug was reported.Further reported, the pt's first surgery was anterior cruciate ligament (acl) repair and it was found that he had no meniscus and was bone on bone.Concomitant medications included insulin glargine (lantus) (since 1997 or 1998) and insulin lispro (humalog).On an unk date, the pt initiated treatment with synvisc one injection, at a dose of 6 ml (route, frequency, batch/lot and expiration date not provided) for knee pain.The pt reported that the injections were painful and if he did something like mow the lawn, his knee would swell to 2.5 times its size and he had to ice it.The pt also reported that it was painful and disturbed his sleep.Further reported the pt took hydrocodone bitartrate/paracetamol (vicodin) for pain as well.On unk dates, the pt also had other surgeries on his elbow and finger and was trying to get a future surgery for rotator cuff repair and knee replacement.It was reported that on an unk date, the pt's hba1c was 8.1% and had decreased to 7.8%.Further reported, the last 2 surgeries would not be done until hba1c was 7%.It was reported that the pt could not read the lot number due to pharmacy label, but thought the expiration was september 2015 on his last vial.Further reported, the physician had given him lantus solostar samples to use since he could not afford his insulin due to insurance issues.He said once he tried to use just 10 units of insulin glargine to conserve, but this did not work.It was reported, the pt was supposed to use one touch ultra test strips and test his blood sugar four times a day.The pt stated that he sometimes reuses the needles.On an unk date in 2014, treatment with synvisc one was completed.Action taken: unk.Outcome unk.A pharmaceutical technical complaint (ptc) was initiated and conclusion was pending for the same.Reporter's casualty assesment: not reported for all events.Co causality assessment: not associated for the event of his hba1c was 8.1% and has decreased to 7.8% and associated for all the remaining events.Seriousness assessment: hospitalization or prolongation for the events of surgeries, surgery on elbow and finger and blood sugar goes from 500 mg/dl and last week down to 32 mg/ml.Pharmacovigilance comment: sanofi co comment dated (b)(4) 2014: in this case, the causal role of synvisc one cannot be excluded for the occurrence of the event of surgery; however, the lack of info regarding the underlying med history and the concomitant medications used by the pt precludes the complete case assessment.

• Brand Name: SYNVISC ONE
• Type of Device: INTRA-ARTICULAR HYALURONIC ACID
• Manufacturer (Section D): GENZYME BIOSURGERY; ridgefield NJ
• Manufacturer Contact: kristen sharma, md ; 55 corporate drive; mail stop 55c-235a; bridgewater, NJ 08807 ; 9089812784
• MDR Report Key: 4147276
• MDR Text Key: 4930689
• Report Number: 2246315-2014-34549
• 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: Study,Consumer
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HUMALOG - ONGOING; LANTUS - ONGOING
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR