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

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.

• 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 Key: 9881114
• MDR Text Key: 187925732
• Report Number: 3007093114-2020-00005
• 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: 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 Number: 630-254
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/25/2020
• 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 Number: 1
• Patient Outcome(s): Required Intervention