MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC 15 MG/ML SYRINGE 2ML, 30MG/2; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Reported pt has ovarian cancer and on chemotherapy.No add'l info provided.Pt does not consent to be contacted.Reporter doesn't consent for mfr f/u.

• Brand Name: ORTHOVISC 15 MG/ML SYRINGE 2ML, 30MG/2
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 13938244
• MDR Text Key: 288210470
• Report Number: MW5108558
• Device Sequence Number: 1
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2022
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 87 KG