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

Model Number	630-254
Health Effect - Clinical Codes	Itching Sensation (1943); Rash (2033)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SODIUM HYALOURONATE FOR INTRA ARTICULATE INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins avenue; bedford MA 01730
• MDR Report Key: 12125567
• Report Number: 3007093114-2021-00179
• Device Sequence Number: 19179974
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 630-254
• Device Catalogue Number: 630254
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 08/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MW5101325
• Patient Sequence Number: 1