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

Catalog Number 6301182010

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Device Markings/Labelling Problem (2911)

Patient Problem Paralysis (1997)

Event Type  Injury  

Event Description

Paralyzed [paralysis].Off label use of device [wrong location] [off label use of device].Case (b)(6) is a serious spontaneous case received from a consumer in united states.This report concerns a male of unknown age who became paralyzed, after receiving injections in his spine of euflexxa (sodium hyaluronate) solution for injection unknown route of administration, concentration, and dosing regimen, for an unknown indication from an unknown start date to an unknown stop date.The reporter stated that her son's male co-worker received euflexxa injections in his spine, he was paralyzed and "it almost killed him".The event paralyzed was assessed as serious (medically significant).Action taken with euflexxa was unknown.On an unknown date, the outcome of paralyzed was unknown.Concomitant medication and medical history were not reported.At the time of reporting the case outcome was unknown.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: case number, others = (b)(6).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)(6) because it did not occur in a (b)(6) 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: 7345508
• MDR Text Key: 102627893
• Report Number: 3000164186-2018-00009
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• 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: 02/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other