MAUDE Adverse Event Report: DEPUY MITEK / ANIKA THERAPEUTICS, INC. MONOVISC (HYALURONATE SODIUM, STABILIZED); ACID, HYALURONIC, INTRAVASCULAR

Lot Number 0000004864

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

Monovisc (hyaluronate sodium, stabilized) injection for a patient was found to have white material floating in the syringe.Ndc 59676-0820-01 lot # 0000004864 manufact: depuy mitek.

• Brand Name: MONOVISC (HYALURONATE SODIUM, STABILIZED)
• Type of Device: ACID, HYALURONIC, INTRAVASCULAR
• Manufacturer (Section D): DEPUY MITEK / ANIKA THERAPEUTICS, INC.
• MDR Report Key: 11752233
• MDR Text Key: 248545231
• Report Number: MW5101085
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676082001
• UDI-Public: 59676-0820-01
• Combination Product (y/n): Y
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0000004864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/29/2021
• Patient Sequence Number: 1