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

Catalog Number 6301182010

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

Patient Problems Dyspnea (1816); Pain (1994); Sore Throat (2396)

Event Type  Injury  

Event Description

Trouble breathing [dyspnoea].Sore throat [oropharyngeal pain].Case (b)(4) is a serious spontaneous case received from a health professional via the fda in united states.This report concerns a patient (no patient identifiers reported), who experienced trouble breathing and sore throat during treatment with intra-articular euflexxa (sodium hyaluronate) 10 mg solution for injection at an unknown dose, for osteoarthritis from an unknown start date to an unknown stop date.The patient went to the hospital emergency room on unspecified dates in (b)(6) 2019 and the present for trouble breathing.The patient reported having a sore throat for the past few months and had been through two rounds of amoxicillin and a round of prednisone.No additional information was provided.The patient was hospitalised on an unknown date due to trouble breathing.Action taken with euflexxa was unknown.At the time of this report, the outcome of trouble breathing and sore throat was unknown.The following concomitant medication was reported: haloperidol (from an unknown start date to an unknown stop date).The event trouble breathing was reported as serious.The event sore throat was reported as non-serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: internal # - others = mw5089089.This ae occurred in united states 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.

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; be'er tuvia industrial zone; pob 571; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 9148287
• MDR Text Key: 167631337
• Report Number: 3000164186-2019-00041
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2019

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: No Information
• Device Catalogue Number: 6301182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 10/02/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization