MAUDE Adverse Event Report: DEPUY SYNTHES ORTHOVISC

Lot Number 160039A

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 10/26/2016

Event Type  Other  

Event Description

One of our orthopedic physicians attempted to inject a pt with orthovisc in their joint, however, while administering the injection, half of the medication came out the side of the syringe near where the needle connects, but not directly at that joint (the other half was injected into the pt).A few of our orthopedic surgeons have said this has happened to them with the past year, but not recently.

• Brand Name: ORTHOVISC
• Type of Device: ORTHOVISC
• Manufacturer (Section D): DEPUY SYNTHES
• MDR Report Key: 6066670
• MDR Text Key: 58981418
• Report Number: MW5065689
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676-0360-01
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 160039A
• Was Device Available for Evaluation?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: TRAMADOL