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U.S. Department of Health and Human Services

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

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ANIKA THERAPEUTICS, INC ORTHOVISC SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
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.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM 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 Key7549310
MDR Text Key109399657
Report Number3007093114-2018-00006
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
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 Received05/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN170045B AND N170064A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
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