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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Manufacturer Narrative

We have no additional information at this time.We have made multiple attempts to contact the reporter and attain more information about this case.(b)(4).Please find the original submission (26jan2017) from the test account.

Event Description

Voluntary report was submitted to the fda on 19dec2016: notified of recent hospitalization via insurance claims.Diagnosis for admission n39.) uti site not specified, admit date 2016, discharge date 2016, dose or amount:30 mg, frequency: weekly for 3 wks, route 1a, dates of use: 2016, diagnosis of reason for use m17.0.Anika was informed about this event via letter from the fda received 09jan2017.This letter references report number mw5066764.Anika has made various documented attempts to attain additional information on this case without success.At this time there is no new information to report.Should any new information be received we will submit accordingly.

Manufacturer Narrative

We have no additional information at this time.We have made multiple attempts to contact the reporter and attain more information about this case.This report was originally filed on 03feb2017 on the test server.The account was recently moved to the production server on 7august2017.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 Description

Voluntary report was submitted to the fda on 19dec2016: notified of recent hospitalization via insurance claims.Diagnosis for admission n39.) uti site not specified, admit date 2016, discharge date 2016, dose or amount:30 mg, frequency: weekly for 3 wks, route 1a, dates of use: 2016, diagnosis of reason for use m17.0 anika was informed about this event via letter from the fda received 09jan2017.This letter references report number mw5066764.Anika has made various documented attempts to attain additional information on this case without success.At this time there is no new information to report.Should any new information be received we will submit accordingly.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: laura smith ; 32 wiggins ave; bedford, MA 01730 ; 7814579287
• MDR Report Key: 6786266
• MDR Text Key: 82700242
• Report Number: 3007093114-2017-00001
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• PMA/PMN Number: 090031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016,08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2016
• Date Report to Manufacturer: 01/09/2017
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization