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

Catalog Number 630254

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

Patient Problems Bruise/Contusion (1754); Head Injury (1879); Headache (1880); Pain (1994); Syncope/Fainting (4411); Unspecified Tissue Injury (4559)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Additional information has been solicited.This case is still under investigation.A supplemental report will be submitted upon completion of the investigation by the manufacturing plant.

Event Description

On 17nov2021 it was reported to anika that a patient received an injection, the patient reported more pain than a previous orthovisc injection (additional information was not provided).Once the patient left the clninics office, the patient passed out and hit the patient's head.Patient also reported having headaches.The patient reported having bruises on the hip, shoulder and head.It is unknown if the patient received any medical intervention after the treatment or fall.Additional information was solicited.Patient demographics is unknown.There was no device malfunction reported.Additional information was solicited.

Manufacturer Narrative

Additional information has been solicited.This case is still under investigation.A supplemental report will be submitted upon completion of the investigation by the manufacturing plant.Supplemental information 28dec2021.Additional information was not provided upon request.It is unknown if the patient required medical intervention.The lot number was not provided.A batch record was not performed.This reported event will be monitored for trending.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

On 17nov2021 it was reported to (b)(6) that a patient received an injection, the patient reported more pain than a previous orthovisc injection (additional information was not provided).Once the patient left the clinics office, the patient passed out and hit the patient's head.Patient also reported having headaches.The patient reported having bruises on the hip, shoulder and head.It is unknown if the patient received any medical intervention after the treatment or fall.Additional information was solicited.Patient demographics is unknown.There was no device malfunction reported.Additional information was solicited.Supplemental information 28dec2021: additional information was not provided upon request.It is unknown if the patient required medical intervention after falling.There was no allegation of a device malfunction.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• Manufacturer Contact: 32 wiggins avenue; bedford, MA 01730
• MDR Report Key: 12977616
• MDR Text Key: 282336948
• Report Number: 3007093114-2021-00315
• 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: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/10/2021
• Supplement Dates Manufacturer Received: 11/17/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1