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

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

Patient Problems Pain (1994); Injection Site Reaction (4562); Swelling/ Edema (4577)

Event Date 12/05/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023 it was reported to anika that a patient of unknown age and demographics received three orthovisc injections.The injection dates were (b)(6) 2022.The name and address of the clinic who injected the patient is unknown.The patient reported experiencing swelling of the lips, itching around the knee, redness and pain.It is unknown when the patient started experiencing the reactions relevant to the injection dates.The patient subsequently went to a dermatologist and was prescribed mometasone furoate cream 1%.The current status of the patient is unknown.There was no report of a malfunction or appearance issues with the device at the time of use.Additional information was solicited.

Event Description

On 17 january 2023 it was reported to anika that a patient of unknown age and demographics received three orthovisc injections.The injection dates were (b)(6) 2022.The name and address of the clinic who injected the patient is unknown.The patient reported experiencing swelling of the lips, itching around the knee, redness and pain.It is unknown when the patient started experiencing the reactions relevant to the injection dates.The patient subsequently went to a dermatologist and was prescribed mometasone furoate cream 1%.The current status of the patient is unknown.There was no report of a malfunction or appearance issues with the device at the time of use.Additional information was solicited.

Manufacturer Narrative

This case is still under investigation at the manufacturing plant.Additional information has been solicited.A supplemental report will be submitted upon receipt of new and relevant information or upon completion of the investigation at the manufacturing plant.Supplemental submission: additional information was not provided upon request.The lot number was not provided.A batch record review could not be performed.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.

• 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: 16334504
• MDR Text Key: 309145981
• Report Number: 3007093114-2023-00004
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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