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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Rash (2033); No Code Available (3191)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

In pma# section of this form, the combination product option was already checked off.I was unable to un-check this option.Please note that orthovisc is not a combination product.

Event Description

The customer reported via phone that after the second injection of orthovisc the patient experienced hives on their body, nausea, vomiting and required hospitalization.The patient received the injection in one knee.The customer could not provide the lot number.The device was discarded after use.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALOURONATE FOR INTRA-ARTICULAR INJECTION
• Manufacturer (Section D): ANIKA THERAPEUTICS; 32 wiggins ave; bedford MA 01730
• Manufacturer (Section G): ANIKA THERAPEUTICS; 32 wiggins ave; bedford MA 01730
• Manufacturer Contact: armando botelho ; 32 wiggins ave; bedford, MA 01730 ; 7814579500
• MDR Report Key: 6774630
• MDR Text Key: 82070773
• Report Number: 3007093114-2017-00015
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 10886705023110
• UDI-Public: 10886705023110
• Combination Product (y/n): Y
• 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: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization