MAUDE Adverse Event Report: DEPUY MITEK / ANIKA THERAPEUTIC, INC. MONOVISC 88MG/4ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Output Problem (3005)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Pt reported he is in pain due to delay with delivery to mdo.Pt also reported he was hospitalized.(b)(6).

• Brand Name: MONOVISC 88MG/4ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): DEPUY MITEK / ANIKA THERAPEUTIC, INC.
• MDR Report Key: 12348464
• MDR Text Key: 267721999
• Report Number: MW5103374
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676082001
• UDI-Public: 59676082001
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization