MAUDE Adverse Event Report: BIOVENTUS LLC SUPARTZ FX PFS ; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Defective Component (2292)

Patient Problem Injury (2348)

Event Type  malfunction  

Event Description

Spontaneous call from patient reported that medication was damaged when the doctor opened it.The doctor stated that the syringe id was not on correctly.Unknown if patient experience an adverse event due to the defective product.Unknown if the patient has the product on hand.Spontaneous call.No additional information.Frequency: once weekly for 2 weeks.Reported to (b)(6) by: patient/caregiver.

• Brand Name: SUPARTZ FX PFS
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 9495866
• MDR Text Key: 172409273
• Report Number: MW5091756
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2019
• Patient Sequence Number: 1