MAUDE Adverse Event Report: BIOVENTUS LLC. DUROLANE SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 21105

Device Problems Output Problem (3005); Explosion (4006)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Spontaneous.Pt's spouse reports that one of the durolane syringes received to the md office did not work and exploded; date unknown.Spouse reports pt only received injection on one knee and is in excruciating pain (onset date unknown).Unknown if defective durolane syringe is available for return to manufacturer.Pharmacy is working with manufacturer to obtain a replacement syringe for pt.No further info, details or dates available.Durolane dosing and frequency: inject one syringe intra-articularly to bilateral knees one time at the physician's office.Durolane indication: bilateral primary osteoarthritis of knee.Cimzia indication: ankylosing spondylitis sacral and sacrococcygeal region.Reported to (b)(6) by pt/caregiver.

• Brand Name: DUROLANE SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): BIOVENTUS LLC.
• MDR Report Key: 17172756
• MDR Text Key: 317648973
• Report Number: MW5118492
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 21105
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female