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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Weakness (2145); Chills (2191); Shaking/Tremors (2515)

Event Type  Injury  

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 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
• Type of Device: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• 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: victoria cassell ; 32 wiggins ave; bedford, MA 01730 ; 7814579000
• MDR Report Key: 6963201
• MDR Text Key: 89797371
• Report Number: 3007093114-2017-00022
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: (01)10886705023110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization