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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fall (1848); Malaise (2359); Loss of consciousness (2418)

Event Date 10/26/2018

Event Type  Injury  

Event Description

Lost consciousness [loss of consciousness].Fell [fall].Got sick [malaise].Case (b)(4) is a serious spontaneous case received from a pharmacist via a regulatory authority in the united states.This report concerns a female of unknown age who lost consciousness, fell, and got sick during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg/ml, dosing regimen unknown, for osteoarthritis (beginning on 2018 and ongoing).The reporter stated that the patient received the euflexxa injection on wednesday ((b)(6) 2018) at her doctor's office and following "got sick" on friday ((b)(6) 2018).Furthermore, the patient lost consciousness and fell.Subsequently, the patient went to the emergency room (er) where they a ct (computerised tomogram) scan and mri (nuclear magnetic resonance imaging) were performed; however, in the er they were unable to identify a cause.The results of ct scan and mri were not specified.The patient's next euflexxa injection was scheduled for next wednesday ((b)(6) 2018).Action taken with euflexxa was reported as dose not changed.The following concomitant medication was reported: losartan (from unknown start to unknown stop date).The event lost consciousness was reported as serious.The events fell, got sick were 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: e2b report duplicate = mw5081160.These aes occurred in united states and concerns the medical device euflexxa.Please report to your local health authority if required by local law.These aes are not reportable in eu because they 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: 8143284
• MDR Text Key: 129657326
• Report Number: 3000164186-2018-00040
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• 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
• Date Manufacturer Received: 11/19/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LOSARTAN
• Patient Outcome(s): Other