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U.S. Department of Health and Human Services

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

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ANIKA THERAPEUTICS INC ORTHOVISC; SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION Back to Search Results
Model Number 630-254
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Embolus (1830)
Event Date 02/20/2020
Event Type  Injury  
Event Description
It was reported by the patient assistance group that patient stated she is waiting for a knee replacement and needs to use the orthovisc.She got a double blood clot and had to go to the hospital where she received pharmacological treatment.No additional information was provided.
 
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Brand Name
ORTHOVISC
Type of Device
SODIUM HYALURONATE FOR INTRA-ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS INC
32 wiggins ave
bedford, ma
Manufacturer Contact
rebecca obeng
32 wiggins ave
bedford, 
4579000
MDR Report Key9881114
MDR Text Key187925732
Report Number3007093114-2020-00005
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier10886705023110
UDI-Public10886705023110
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 Other
Type of Report Initial
Report Date 03/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number630-254
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/24/2020
Initial Date FDA Received03/25/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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