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 Fall (1848); Bone Fracture(s) (1870)

Event Date 12/20/2019

Event Type  Injury  

Event Description

Lost balance [balance disorder].Had fallen and broken her arm [fall].Had fallen and broken her arm [upper limb fracture] case (b)(4) is a serious spontaneous case received from a non-health professional via regulatory authority in united states.This report concerns a female of an unknown age who had lost balance, had fallen and broken her arm during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 10 mg, unknown dose, route and frequency, for an unknown indication from an unknown start date to an unknown stop date.The patient had lost balance, had fallen and broken her arm.The patient was hospitalized on an unknown date due to lost balance, had fallen and broken her arm.Action taken with euflexxa was unknown.At the time of this report, the outcome of lost balance, had fallen and broken her arm was unknown no concomitant medication was reported.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Ferring's sender comment: association of euflexxa to lost balance, fall, and broken her arm events are considered unrelated due to lack of biological plausibility.Overall listedness (core label) is unlisted.Reporter causality: related company causality: not related other case numbers: internal # - others = mw5092963 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 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 ; 3044828
• MDR Report Key: 9836776
• MDR Text Key: 183653128
• Report Number: 3000164186-2020-00006
• 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
• Type of Report: Initial
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• 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: L14134A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization