MAUDE Adverse Event Report: ANIKA THERAPEUTICS INC. ORTHOVISC INJ 15MG/ML

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 02/18/2018

Event Type  Injury  

Event Description

Pt is reporting lot of itching in her abdominal areas after orthovisc inj.Advised her to take some antihistamine and apply 1 percent hc cream.Also advised her to contact her md and let them know about itching.Is the product compounded: no.Is the product over-the counter: no.

• Brand Name: ORTHOVISC INJ 15MG/ML
• Type of Device: ORTHOVISC INJ 15MG/ML
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.
• MDR Report Key: 7288870
• MDR Text Key: 100795116
• Report Number: MW5075408
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 59676036001
• UDI-Public: 59676036001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 81 YR