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

Model Number 630-254

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

Patient Problems Edema (1820); Swelling (2091); Reaction (2414); Coma (2417)

Event Date 12/10/2014

Event Type  Injury  

Event Description

Clinic reported: patient is a (b)(6) yo, male.Hx of renal failure on lisinopril only.Had a last cortisone injection for his oa on (b)(6) 2014, with no reported events.Received "first" ov injection on (b)(6) 2014 at ~08:45.Standard chloro skin prep.No concomitant meds given (anesthetic or cs) with orthovisc.No complaints at injection time from patient.Later that night, patient started severe tongue angioedema.Transported to ed, with first bp (150/67) recorded at 03:24.Ed was concerned with anaphylaxis/swelling and patient was put into induced coma for ~3 days.Patient stable and d/c off lisinopril.Hospital staff believes lisinopril primary cause, but triggering event could have been orthovisc.Recommended no more injections.

Manufacturer Narrative

The device was not available to be returned.No further evaluation is possible.Device not returned to manufacturer.

• Brand Name: ORTHOVISC
• Type of Device: SODIUM HYALURONATE FOR INTRA-ARTICUL
• Manufacturer (Section D): ANIKA THERAPEUTICS INC.; 32 wiggins ave; bedford MA 01370
• Manufacturer (Section G): ANIKA THERAPEUTICS INC; 32 wiggins ave.; bedford MA 01730
• Manufacturer Contact: stephanie bunch ; 32 wiggins ave.; bedford, MA 01730 ; 7814579000
• MDR Report Key: 4366906
• MDR Text Key: 5115706
• Report Number: 3007093114-2014-00005
• Device Sequence Number: 1
• Product Code: MOZ
• 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: 12/29/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 630-254
• Device Lot Number: N140052B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 55 YR