MAUDE Adverse Event Report: ORTHOGENRX, INC. GENVISC 850 INJ 25/2.5; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 08/29/2017

Event Type  malfunction  

Event Description

Md attempted to give pt genvisc injection and medication leaked from syringe where needle meets syringe barrel.This was 3rd injection in series of 5; md had additional syringes on hand to give injection.No delay in therapy.Dose or amount: 25 mg.Frequency: qweek.Route: ia.Dates of use: (b)(6) 2017.Diagnosis or reason for use: osteoarthritis.Is the product compounded: no.Is the prodcut over-the-counter: no.

• Brand Name: GENVISC 850 INJ 25/2.5
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ORTHOGENRX, INC.
• MDR Report Key: 6839048
• MDR Text Key: 84713859
• Report Number: MW5071907
• Device Sequence Number: 0
• Product Code: MOZ
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• 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: 09/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR