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

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

Patient Problems Itching Sensation (1943); Urticaria (2278); Reaction (2414)

Event Date 07/10/2020

Event Type  Injury  

Event Description

Pt experienced allergic reaction itching and hives from orthovisc per daughter since (b)(6) 2020 friday; pt already followed up with md and taken zyrtec today.Advised to go to er if any breathing problem or swelling in throat areas.Advise to followup with primary md to evaluate before continuation of orthovisc therapy; however, pt maybe allergic to (b)(6) detergent, counsel to try benadryl tomorrow if zyrtec does not work.

• Brand Name: ORTHOVISC PFS 30MG/2ML
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 10295096
• MDR Text Key: 199715645
• Report Number: MW5095586
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/16/2020

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR