MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)

Event Date 01/11/2021

Event Type  Injury  

Event Description

Had bad rash that extended to all parts of body.Started getting lesions on skin mostly on thigh area to begin with and terrible itching on back.That to see my doctor, dermatologist, and neurologist before deferring what it was from.Biopsies of breakouts from dermatologist non-malignant, creams to deal with itching.As i read on a mayo clinic report on knee gel that was given to me in mid (b)(6) 2020- (b)(6) 2021 was listed as low common symptoms to some this gel, but i was one suffering form low common symptoms.Doctor used product to treat bone on bone knee.It has a six-month duration period which should end about end of (b)(6).This is redundant.Already gave meds and problem that caused my problem causing outbreaks, severe itching and breaking out all over body and to date is still breaking out and i'm using creams to treat this.

• Brand Name: ORTHOVISC
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.
• MDR Report Key: 11817387
• MDR Text Key: 250885278
• Report Number: MW5101325
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/04/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 63