MAUDE Adverse Event Report: ANIKA THERAPEUTICS, INC. ORTHOVISC; SODIUM HYALURONATE FOR INTRA-ARTICUL, PRODUCT CODE: MOZ

Model Number 630-254

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

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Confusion/ Disorientation (2553)

Event Type  Injury  

Manufacturer Narrative

Device not available for return.

Event Description

The patient reported she had 3 orthovisc injections around (b)(6) 2016 from dr.(b)(6) at (b)(6).Her dob is (b)(6).She had positive results with the first 2 shots where it helped her knee and had no symptoms.She has arthritis and had fluid in her knee prior to the shots.However, fluid was removed before the first 2 injections.After the 3rd injection, within hours, she had redness, pain, flu-like symptoms, confusion, ankle swelling, aches and a rash which began to spread up her back.She also had itching on her scalp which led to soars on her scalp.She went to a dermatologist who advised her it was an allergic reaction and gave her 25 cortisone shots with no help.She went to an endocrinologist who stated she needs to see a rheumatologist where it may be connected tissue disease.Connie was concerned with the longevity of these effects as it is getting worse and wanted to know what to do and if this can spread to her brain.I advised her to contact her dr.Immediately for all medical advice and she will keep in touch with me as she has an appointment tuesday with a rheumatologist.After i disconnected the call, i reached out to dr.(b)(6)'s office on 22jul2016 where i spoke to (b)(6), his nurse.I advised her of the patient's complaint and asked for lot #'s of all 3 injections.She said she will get back to me.Update: (b)(6), the nurse from dr.(b)(6)'s office called back on (b)(6) 2016 and provided me with the lot # of injections 1 and 3 as n150087a.She is still researching the lot # on the 2nd injection and will get back to me as new information becomes available.She also stated connie has since called in and she is advising her.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICUL, PRODUCT CODE: MOZ
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: eric blais ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 5829113
• MDR Text Key: 50649683
• Report Number: 3007093114-2016-00006
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): N
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: 630-254
• Device Lot Number: N150087A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/07/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 67 YR