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 04/01/2022

Event Type  Injury  

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 01may2023 it as reported to anika that a female patient was treated with orthovisc on or about (b)(6) 2022 and experienced a "systemic rash".The patient visited a urgent care and was prescribed a prednisone titrating dose and an antihistamine (brand unknown) during the day.Additional information was not provided.There was no report of a malfunction or appearance issue with the device at the time of the injection.The lot number was not provided.Additional information was solicited.

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.

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: the reported event is not confirmed.The cause of the reported event cannot be confirmed.A clinical assessment concluded that the patient may have been hypersensitive to orthovisc.Additional information was solicited but not provided.There was no report of any malfunction or appearance issues with the device at the time of use.The current status is unknown.The batch record could not be reviewed.The lot number was not provided.All product is manufactured and released to applicable procedures and specifications.The reported event will continue to be monitored and trended for future analysis.A supplemental report will be submitted upon receipt of new and relevant information.

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 01may2023 it as reported to anika that a female patient was treated with orthovisc on or about (b)(6) 2022 and experienced a "systemic rash".The patient visited a urgent care and was prescribed a prednisone titrating dose and an antihistamine (brand unknown) during the day.Additional information was not provided.There was no report of a malfunction or appearance issue with the device at the time of the injection.The lot number was not provided.Additional information was solicited.

• 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: 16992421
• MDR Text Key: 315865595
• Report Number: 3007093114-2023-00085
• 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: 06/28/2023

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: Health Professional
• Device Catalogue Number: 630254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2023
• Initial Date FDA Received: 05/24/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 06/28/2023
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 73 KG