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

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Weakness (2145); Chills (2191); Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time no event date or lot number was reported.If the information become available then a follow up report will be made.
Event or Problem Description
An email was forwarded to mitek cqg concerning an orthovisc patient.From conversation with mr.Marcus pierce this morning, we learned that he has had 2 injections of orthovisc and per his physician's recommendation has stopped the 3rd injection due to, what they believe to be allergy related symptoms.(b)(6) first noticed the symptoms after the 1st injection, he said that the symptoms were like flu, the chills, the weakness, the shakes, but taught nothing of it.The 2nd injection, pretty much the same except that this time it was more severe and that he had uncontrollable shakes and ended up in the er.Tests were done and the results pointed to possible allergies of the orthovisc.(b)(6)., herself a nurse, was a bit upset because she did contact the orthovisc line, spoke to the nurse there and was told that someone was going to call back.It's been a week.She would like to speak to someone who is knowledgeable with the product and would be able to answer her questions.

• Brand Name: ORTHOVISC
• Common Device Name: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS, INC.; 32 wiggins ave; bedford MA 01730
• MDR Report Key: 6963201
• Report Number: 3007093114-2017-00022
• Device Sequence Number: 18974419
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: (01)10886705023110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P030019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization