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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 UNKNOWN
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Edema (1820); Swelling (2091); Patient Problem/Medical Problem (2688)
Event Date 12/10/2019
Event Type  Injury  
Manufacturer Narrative
On 15jan 2020, patient report received did not meet the criterial for reporting the incidence. On 29 january 2020, additional information received led to the need for medical device report. This case is reported on 06 february 2020.
 
Event Description
On 15 january 2020, (b)(6) from (b)(6) called anika to report that she was experiencing possible allergic reaction to an orthovisc injection and it was provoked in her knee. The same reports was received from this patient through the fda medwatch report mw5092019. On 29 january 2020, patient provided additional information on this case. Patient reported having the orhovisc treatment on (b)(6) 2019 and on (b)(6), experience allergic reaction (hives and rashes over entire body, swelling of feet, knees, and calves, and toes with clear liquid). Patient reported refusing the third injection due to these allergic reactions. Patient reported she had in the past used supartz treatment every six months for several decades because she no longer have meniscus in either knee. Patient reported never experiencing allergic reaction after supartz treatment.
 
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Brand NameORTHOVISC
Type of DeviceSODIUM HYALURONATE FOR INTRA ARTICULAR INJECTION
Manufacturer (Section D)
ANIKA THERAPEUTICS INC
32 wiggins ave
bedford MA 01730
Manufacturer Contact
rebecca obeng
32 wiggins ave
bedford, MA 01730
7814579254
MDR Report Key9678106
MDR Text Key187926629
Report Number3007093114-2020-00004
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P030019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/06/2020 Patient Sequence Number: 1
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