MAUDE Adverse Event Report: ORTHOVISC INJ 15MG/ML; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Missed Dose (2561)

Event Date 06/01/2017

Event Type  Injury  

Event Description

Pt missed his dose because he moved and needed to get a new doctor."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• MDR Report Key: 7212146
• MDR Text Key: 98082559
• Report Number: MW5074734
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676036001
• Combination Product (y/n): N
• 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: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2018
• 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 Age: 64 YR