MAUDE Adverse Event Report: FIDIA FARMACEUTICI SPA HYALGAN PFS; ACID, HYALURONIC, INTRAARTICULAR

Lot Number E16670

Device Problems Inaccurate Delivery (2339); Misfire (2532)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Spontaneous call from md office spoke to (b)(6) rn: upon injection hyalgan, md reports "misfire" of syringe.Only able to dispense part of the medication.No other information available.Indication: unilateral primary osteoarthritis, right knee.Reported to (b)(6) by health professional.

• Brand Name: HYALGAN PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): FIDIA FARMACEUTICI SPA
• MDR Report Key: 12728630
• MDR Text Key: 279814964
• Report Number: MW5105056
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/10/2024
• Device Lot Number: E16670
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR