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

Model Number N/A

Device Problem Missing Value Reason (3192)

Patient Problems Pain (1994); Swelling (2091)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Report was received on 27 of march 2018, it was determined at that time not to be a reportable event.On 06 of june 2018, new information was provided leading to the need to report this case.Mdr was filed today, 27 of june 2018.

Event Description

Case received on 27march2018: patient received a single orthovisc injection on (b)(6) 2018 (tolerated without difficulty).On (b)(6) 2018 patient presented knee pain and was treated with morphine injection and rx for motrin.On (b)(6) 2018 patient complained of swelling and pain, treated with 40 mg of kenalog w/ lidocaine to reduce swelling.On (b)(6) 2018, patient states that pain has continued and has been ordered for an mri.Awaiting mri results as of (b)(6) 2018.Update information leading to mdr filing received on 06june2018: reaction occured within 48 hours of injection.Patient was treated with an incision and drainage of the afflicted knee.Lot number was also provided on this date.

• 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: victoria cassell ; 32 wiggins ave; bedford, MA 01730 ; 7814579500
• MDR Report Key: 7642604
• MDR Text Key: 112495690
• Report Number: 3007093114-2018-00007
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N170039A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR