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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Headache (1880); Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Rash (2033); Arthralgia (2355); Joint Swelling (2356); Reaction, Injection Site (2442); Abdominal Cramps (2543); Lethargy (2560); Alteration In Body Temperature (2682)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Anaphylactic reaction [anaphylactic reaction], stomach cramps [abdominal pain upper], fever [pyrexia], rash [rash], lethargy [lethargy], flu like symptoms [influenza like illness], neck pain [neck pain], memory problems [memory impairment], knees hurt worse [arthralgia], had trouble breathing [dyspnoea], swelling in all joints [joint swelling], headache [headache], did not work [device ineffective].This serious regulatory authority, complaint, spontaneous report was received from a non health professional in united states.This report concerns a patient of unknown age and gender who experienced anaphylactic reaction, stomach cramps, fever, rash, lethargy, flu like symptoms, neck pain, memory problems, knees hurt worse, had trouble breathing, swelling in all joints, headache, and did not work during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection unknown concentration, for arthralgia from 2016 to 2016.The patient reported that after the first injection of euflexxa they experienced severe stomach cramps.After the second injection (date not provided) they experienced anaphylactic reaction, fever, rash, severe lethargy, headache, and swelling in all joints.They also reported flu like symptoms, neck pain, memory problems, knees hurt worse, and had trouble breathing.The patient reported that euflexxa did not work and refused third set of injections.The anaphylactic reaction was medically significant.Action taken with euflexxa was dose withdrawn.At the time of this report, the outcome of all of the events was unknown.The patient`s past drug therapy was significant for synvisc (from unknown start date to unknown stop date).Concomitant medication use was not reported.At the time of reporting the case outcome was unknown.Ferring global pharmacovigilance added the narrative since no narrative was provided.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: unassessable.Other case numbers: case number, others = mw5065512.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 does not meet the definition of a medical device incident according to the requirements of the medical device directive, 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 performed by the manufacturer or requested by regulators.Argus number: (b)(4).

• Brand Name: EUFLEXXA
• Type of Device: 1% SODIUM HYALURONATE
• Manufacturer (Section D): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD; be'er tuvia industrial zone; kiryat malachi, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 6136266
• MDR Text Key: 61158832
• Report Number: 3000164186-2016-00039
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• 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: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other