MAUDE Adverse Event Report: ANIKA ORTHOVISC; SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.

Catalog Number 630254

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Date 04/05/2023

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 10april2023 it was reported to anika that a 64 year old female patient of unknown demographics received a bilateral orthovisc injection of the knee on or about (b)(6) 2023.The patient underlying condition is bilateral knee osteoarthritis.No fluid was removed from the patient's knee prior to the injection.The patient was injected with a full dose.A 22 gauge needle was used for the injection.Post injection protocol was ice, and 24-48 hours of rest.The patient subsequently experienced a systemic rash after the injection.The date the rash appeared was not provided.The patient was prescribed medrol by the healthcare provided.The current status of the patient is unknown at this time.Additional information was solicited.This is one of two reportable complaints related to the same patient.

Event Description

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report does not reflect a conclusion by anika or its employees that the report constitutes an admission that the device, anika, or its employees caused or contributed to a potential patient event documented on this report.On 10april2023, it was reported to anika that a 64 year old female patient of unknown demographics received a bilateral orthovisc injection of the knee on or about (b)(6) 2023.The patient underlying condition is bilateral knee osteoarthritis.No fluid was removed from the patient's knee prior to the injection.The patient was injected with a full dose.A 22 guage needle was used for the injection.Post injection protocol was ice, and 24-48 hours of rest.The patient subsequently experienced a systemic rash after the injection.The date the rash appeared was not provided.The patient was prescribed medrol by the healthcare provided.The current status of the patient is unknown at this time.Additional information was solicited.This is one of two reportable complaints related to the same patient.

Manufacturer Narrative

This case is still under investigation.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation by the manufacturing plant.Supplemental report: a 64 year old patient received bilateral ia orthovisc injections to both knees for a diagnosis of bilateral knee osteoarthritis (oa).Per the report patient followed the post injection protocol and applied ice to the knees and rested for 24-48 hours.The patient reported back to the clinic for a second dose of orthovisc injections and it appears that she reported having developed a systemic rash following injection #1.The report states that symptoms began within a few days after the injection (unclear as to the exact timeframe) and was provided with a medrol pack during the visit for the second injections.No specific details are provided in the complaint as to whether the rash was present at the visit for the second injections and or if they were accompanied by any other symptoms such as breathing difficulties, fever of other complaints.It is noted that the patient did not seek medical help at the time of the rash but mentioned it at the scheduled visit for the second injections, which were withheld.Probable reaction to orthovisc, transient.Unclear if patient was prescribed the medrol pack for the reaction or just in case the symptoms progressed.The device was not returned to the manufacturing plant.Additional information was not provided upon request.There was no report of any device malfunction at the time of use of the device.A review of the batch record was performed.A planned deviation was recorded in the manufacturing records.The planned deviation was not related to the reported event.The product was manufactured and released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemenal report will be submitted upon receipt of new and relevant information.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION.
• Manufacturer (Section D): ANIKA; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: keith kelly ; 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 16853210
• MDR Text Key: 314391407
• Report Number: 3007093114-2023-00015
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 630254
• Device Lot Number: 0000007062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG