MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. MONOVISC SYRINGE; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0000003973

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Call from physician's office who reported that when md was going to inject syringe, needle was screw onto end when plunger was push the syringe exploded on her.No adverse event occurred.Patient didn't miss any doses.No further information available.Unknown if device is available for return.Janssen products.Reported to (b)(6) by health professional.

• Brand Name: MONOVISC SYRINGE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 10546563
• MDR Text Key: 207581576
• Report Number: MW5096713
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2022
• Device Lot Number: 0000003973
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1