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

Catalog Number 6301182010

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Date 04/04/2018

Event Type  Injury  

Event Description

Left leg got infected [localised infection].Could not move leg [movement disorder].Case description: case (b)(6) is a serious complaint, spontaneous case received from a non health professional via a regulatory authority in the united states.This report concerns a patient of unknown age and gender whose left leg got infected, could not move leg and experienced internal bleeding during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection, with unknown concentration and dose, for an unknown indication from 2018 to 2018 and the co-suspect drug xarelto (rivaroxaban), with unknown concentration, dose and route of administration, for an unknown indication on unknown dates.The patient was injected in both knees with euflexxa on an unspecified date in 2018.On (b)(6) 2018 the patient's leg got infected and they could not move their leg.The patient had their leg scoped on an unspecified date to determine the type of infection.The patient was placed on unspecified antibiotics through a peripherally inserted catheter (pic) line.The patient experienced internal bleeding from xarelto and had to have five pints of blood transfused.They were hospitalized for seven days, were in rehabilitation for seven days and then underwent rehabilitation at home for one month.No additional information was reported.The events of leg infection, could not move leg and internal bleeding were serious due to hospitalization and were medically significant.Action taken with euflexxa was unknown.Action taken with xarelto was unknown.At the time of this report, the outcome of left leg got infected was unknown, the outcome of could not move leg was unknown, the outcome of bleeding internally was unknown.The patient`s procedures included scoped leg (from unknown start date to unknown stop date).The following concomitant medications were reported: amlodipine, atorvastatin, carbidopa, glipizide, metformin.Multivitamin, ocuvite and unspecified over the counter medications.All events in the case were reported as serious.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related company causality: related, event of internal bleeding deemed 'not related'.Other case numbers: case number, others = mw5077555.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 (b)(4) because it did not occur in a (b)(4) 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: 7665491
• MDR Text Key: 113283730
• Report Number: 3000164186-2018-00020
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; ATORVASTATIN; CARBIDOPA; GLIPIZIDE; METFORMIN; MULTIVITAMIN; OCUVITE
• Patient Outcome(s): Hospitalization; Other