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

Model Number 630-254

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033)

Event Date 05/12/2021

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.

Event Description

A patient reported the following to the fda on mw5101325: patient experienced a rash on the body and reported lesions on the skin in the thigh area.Itching was also reported.Patient saw a dermatologist an neurologist and reports using a unspecified cream to treat.Additional information was solicited.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant investigation.Additional information was not provided.The lot number was not provided.A plant investigation was not performed.The reported event will be monitored and trended.A supplemental report will be submitted upon receipt of new and relevant information.

Event Description

A patient reported the following to the fda on mw5101325: patient experienced a rash on the body and reported lesions on the skin in the thigh area.Itching was also reported.Patient saw a dermatologist an neurologist and reports using a unspecified cream to treat.Additional information was solocited.See h10 for additional information.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALOURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12125567
• MDR Text Key: 262565606
• Report Number: 3007093114-2021-00179
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 630-254
• Device Catalogue Number: 630254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5101325
• Patient Sequence Number: 1