MAUDE Adverse Event Report: BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA; 1% SODIUM HYALURONATE

Catalog Number 6301182010

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arthritis (1723); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Bilateral dvt's (deep vein thrombosis).This serious spontaneous report was received from a nurse in united states.This report concerns a (b)(6) female who experienced bilateral dvt's (deep vein thrombosis) during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, weekly, for osteoarthritis from (b)(6) 2016 to an unknown stop date.It was reported that the first euflexxa injection was given on (b)(6) 2016 and the second euflexxa injection was given on (b)(6) 2016.On (b)(6) 2016, the patient experienced bilateral dvt's (deep vein thrombosis).On (b)(6) 2016 the patient went to the emergency room with pain where she was diagnosed with bilateral dvt's (deep vein thrombosis).The bilateral dvt's (deep vein thrombosis) were medically significant.Action taken with euflexxa was unknown.At the time of this report, the outcome of bilateral dvt's (deep vein thrombosis) was not recovered.The following concomitant medication was reported: vitamins (from an unknown start date to an unknown stop date), aspirin (from an unknown start date to an unknown stop date), prednisone (from an unknown start date to an unknown stop date).At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: case number, others = (b)(4).This ae occurred in the us and concerns the medical device euflexxa.Please report to your local health authority if required by local law.This ae is not reportable in eu because it does not meet the definition of a medical device incident according to the requirements of the medical device directive, because it did not occur in a eu + efta country and did not result in a corrective action by the manufacturer no corrective action was done by the manufacturer or requested by regulators.Argus number: (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 6140744
• MDR Text Key: 61307636
• Report Number: 3000164186-2016-00033
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/15/2016

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 Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: ASPIRIN (ACETYLSALICYLIC ACID); PREDNISONE (PREDNISONE); VITAMINS (ASCORBIC ACID, ERGOCALCIFEROL)
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Weight: 121