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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
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ANIKA THERAPEUTICS, INC. ORTHOVISC SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION Back to Search Results
Catalog Number 630254
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Head Injury (1879); Headache (1880); Pain (1994); Syncope/Fainting (4411); Unspecified Tissue Injury (4559)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Additional information has been solicited. This case is still under investigation. A supplemental report will be submitted upon completion of the investigation by the manufacturing plant.
 
Event Description
On 17nov2021 it was reported to anika that a patient received an injection, the patient reported more pain than a previous orthovisc injection (additional information was not provided). Once the patient left the clninics office, the patient passed out and hit the patient's head. Patient also reported having headaches. The patient reported having bruises on the hip, shoulder and head. It is unknown if the patient received any medical intervention after the treatment or fall. Additional information was solicited. Patient demographics is unknown. There was no device malfunction reported. Additional information was solicited.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS, INC.
32 wiggins avenue
bedford MA 01730
Manufacturer Contact
32 wiggins avenue
bedford, MA 01730
MDR Report Key12977616
MDR Text Key282336948
Report Number3007093114-2021-00315
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number630254
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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