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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Urticaria (2278); Toxicity (2333); Reaction (2414)

Event Date 12/10/2019

Event Type  Injury  

Event Description

Pt reports after the second series of orthovisc injection, she had an adverse reaction: hives, rash on body and weeping lesions on her feet.Pt was put on anti-inflammatory meds: keflex 4 times a day for a week, and prednisone for 7 days.

• Brand Name: ORTHOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 9543977
• MDR Text Key: 173743350
• Report Number: MW5092019
• 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: Patient
• Type of Report: Initial
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 77