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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Description

Patient experienced allergic reaction to medication.User went afk, so no further info able to be acquired.Reported by hcp hcp did not give consent to follow-up (b)(6).

• Brand Name: ORTHOVISC 30MG/2ML SYRINGES
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 16042865
• MDR Text Key: 306327922
• Report Number: MW5113949
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/20/2022

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/21/2022
• Patient Sequence Number: 1