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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Underdose (2542)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Fractured left leg [lower limb fracture].Broke a rib [rib fracture].Received 10 mg once weekly for three weeks [underdose].(b)(4) is a serious, spontaneous case received from a health professional via a regulatory authority in the united states.This report concerns a female of unknown age who experienced a fractured left leg, broke a rib and received 10 mg once weekly for three weeks [underdose] during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, with unknown concentration, 10 mg, weekly for 3 weeks, for osteoarthritis from 2015 to an unknown stop date.It was reported that the patient began therapy with euflexxa on an unspecified date in 2015.In (b)(6)2017 the patient broke a rib.In (b)(6) 2018, the patient fractured her left leg and was hospitalized.Treatment during hospitalization was not reported.Date of discharge from the hospital was not reported.Lot number was reported as m17203a with an expiration date of 27-aug-2018.The patient was hospitalized on an unknown date in (b)(6) 2018 due to fractured left leg.Action taken with euflexxa was unknown.At the time of this report, the outcome of received 10 mg once weekly for three weeks was unknown, the outcome of broke a rib was unknown, the outcome of fractured left leg was unknown.Concomitant medication use and medical history were not reported.The event fractured left leg was reported as serious.The events broke a rib, received 10 mg once weekly for three weeks 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: (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 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: 7536280
• MDR Text Key: 109062806
• Report Number: 3000164186-2018-00016
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 08/27/2018
• Device Catalogue Number: 6301182010
• Device Lot Number: M17203A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization