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

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.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM 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 Key: 9678106
• MDR Text Key: 187926629
• Report Number: 3007093114-2020-00004
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• 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 Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR