MAUDE Adverse Event Report: ORTHOVISC INJ 15MG/ML

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Dizziness (2194); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 03/08/2018

Event Type  Injury  

Event Description

Pt reports a lot of pain in right leg and knee.Unable to stand on feet starting a few weeks ago and has worsened since last injection a couple weeks ago.Also reports being shaky and lightheaded.Event abated after use stopped or dose reduced: no.

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: ORTHOVISC INJ 15MG/ML
• MDR Report Key: 7369332
• MDR Text Key: 103535244
• Report Number: MW5076100
• 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: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 81 YR