MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; ACID, HYALURONIC, INTRA ARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/25/2016

Event Type  Injury  

Event Description

Notified of recent hospitalization via insurance claims.Diagnosis for admission n39.0 - urinary tract infection site not specified.Admit date: (b)(6) 2016, discharge date: (b)(6) 2016.Dose or amount: 30mg, frequency: weekly for 3 wk, route: 1a.Dates of use: (b)(6) 2016.Diagnosis or reason for use: m17.0.

• Brand Name: ORTHOVISC
• Type of Device: ACID, HYALURONIC, INTRA ARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 6185609
• MDR Text Key: 62861191
• Report Number: MW5066764
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 5967603600
• UDI-Public: 5967603600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 59 YR