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

Lot Number	UNKNOWN
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report was originally filed on (b)(6) 2017 on the test server.The account was approved and moved to the production server on (b)(6) 2017.I was informed to resubmit all previous files to the production server.Production account approval help desk ticket #(b)(4).Notification of moving files to production account help desk ticket #(b)(4).
Event or Problem Description
"the customer reports that in 2015, her mother (the patient), died two weeks after receiving orthovisc injections in her right knee for knee pain.The reporter also states that the patient experienced nausea, vomiting, diarrhea, and shortness of breath in the two weeks prior to her death.Prior to receiving the orthovisc, the patient contacted the clinic to inform the clinic about all of her medical illnesses and complications.The patient further explained to the clinic some of her allergies and the patient was told that if one in particular (allery) had gone into her bloodstream that it could cause death.During the same conversation between the patient and the clinic, the patient requested product information to present to her nephrologist/doctor for review.The patient's medical conditions/history include: kidney disease, chronic heart failure, and unspecified allergies.The reported dates of the injections are: 1st in (b)(6) 2015 and 2nd in (b)(6) 2015.The reported date of death is (b)(6)2 015.".

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 6789533
• Report Number: 3007093114-2017-00013
• Device Sequence Number: 16180573
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Physician
• Device Lot Number: UNKNOWN
• 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: 06/12/2017
• Initial Report FDA Received Date: 08/11/2017
• 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: Death