MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC ORTHOVISC; SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Rash (2033)
Date of Event	01/15/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient got their second orthovisc injection on saturday (b)(6) and today (b)(6) went to the er with a pretty significant rash all over both legs, arms, left hand, and on her back.The patient is in the er right now.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 7302759
• Report Number: 3007093114-2018-00003
• Device Sequence Number: 1893145
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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
• Operator of Device: Physician
• Device Expiration Date: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N170035A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization