MAUDE Adverse Event Report: FIDIA PHARMA HYALGAN 20MG/2ML

Device Problems Improper or Incorrect Procedure or Method (2017); Improper Device Output (2953); Application Program Problem: Medication Error (3198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2016

Event Type  malfunction  

Event Description

Patient had hyalgan sodium hyaluronate 20mg/2ml ordered (fidia pharma mfr) injection for series of 3 weekly injections.Pharmacy accidentally dispensed synvisc one hylan gf 20 (genzyme mfr).It was administered to patient in clinic.Errors due to product labeling similarities.Hyalgan sodium hyaluronate 20mg/ml and synvisc hylan fg20.Number 1 dose or amount: 20mg syringe ordered; frequency: weekly x3; route: intra articular.Number 2 dose or amount: 48mg syringe given; frequency: once; route: intra articular.Is the product compounded: number one no.Is the product over-the-counter: no.

• Brand Name: HYALGAN 20MG/2ML
• Type of Device: HYALGAN 20MG/2ML
• Manufacturer (Section D): FIDIA PHARMA
• MDR Report Key: 5707022
• MDR Text Key: 46875948
• Report Number: MW5062729
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 89122072420
• UDI-Public: 89122-0724-20
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/06/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 137