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 04/28/2018

Event Type  Injury  

Manufacturer Narrative

Patient received bilateral injections, one syringe in each knee.Two different lots were used for the patient: n170045b and n170064a.Patient experienced swelling in only one knee, but the report did not specify which knee had the swelling.Physician did not clarify which lot was used in the knee that resulted in the swelling.Please find the manufacture and expiration dates for both lots used below: n170045b, manufactured: 06 june 2017, expiration: 30 june 2019.N170064a, manufactured: 14 august 2017, expiration: 31 august 2019.Multiple attempts have been made to gain clarification on this information before reporting, however it was never provided.

Event Description

Patient had first series of bi-lateral knee injections of orthovisc on (b)(6) 2018 from lot number n170045b with no issues.Patient had second series of bi-lateral knee injections of orthovisc on (b)(6) 2018 from lot number n170064a and n170045b.The patient noticed on (b)(6) 2018 swelling on one knee and was difficult to stand.On (b)(6) 2018, the swelling had travelled down to his calf.On (b)(6) 2018 the patient went back to the doctors.Blood work was taken and no infection was present.The doctor did drain 60cc of fluid, then administered an intramuscular injection to calm the swelling.The patient is seeing his doctor on (b)(6) 2018 for a follow up.

• 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: 7549310
• MDR Text Key: 109399657
• Report Number: 3007093114-2018-00006
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N170045B AND N170064A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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