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

Catalog Number 6301182010

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Septic Shock (2068); Swelling (2091); Reaction, Injection Site (2442)

Event Date 12/01/2017

Event Type  Injury  

Event Description

Diagnosed with e.Coli [stomach upset, unable to eat] [escherichia infection].Diagnosed with septic shock [septic shock].Area was swollen [swelling].Area was puffy [swelling].Case (b)(4) is a serious, spontaneous case received from a consumer via a regulatory authority in united states.This report concerns a male of unknown age who experienced swelling and puffiness around the area, and was diagnosed with escherichia coli [stomach upset, unable to eat] and septic shock during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection (concentration and dose unknown), for an unknown indication from an unknown start date to an unknown stop date.It was reported that the patient was injected with euflexxa on (b)(6) 2017.It was reported that the patient saw his physician on the same day who noted the area was swollen and puffy (area was not defined).Five days later, at noon, the patient experienced an upset stomach and was unable to eat.In the evening, the patient's blood pressure was 77/50 with a pulse of 178.The patient was hospitalized on an unknown date for five days.The patient spent three days in the intensive care unit.It was reported that the patient was diagnosed with escherichia coli (e.Coli) and eventually septic shock.It was reported that the patient was feeling much better post discharge.The patient was hospitalized on an unknown date due to septic shock and escherichia coli [stomach upset, unable to eat].Action taken with euflexxa was unknown.At the time of this report, the outcome of diagnosed with e.Coli [stomach upset, unable to eat] was recovering/resolving, the outcome of diagnosed with septic shock was recovering/resolving, the outcome of area was swollen was recovering/resolving, the outcome of area was puffy was recovering/resolving.Concomitant medication use and medical history were not reported.Relevant laboratory values included: blood pressure measurement: 77/50 ni (unknown), (b)(6) 2017.Heart rate: 178 ni (unknown), (b)(6) 2017.The events diagnosed with e.Coli [stomach upset, unable to eat], diagnosed with septic shock were reported as serious.The events area was swollen, area was puffy were reported as non-serious.At the time of reporting the case outcome was recovering/resolving.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: not related.Other case numbers: case number, others = mw5074646.Case numbers, complaint = (b)(4).This ae occurred in the u.S 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; kiryat malachi, 83104 ; IS 83104
• Manufacturer (Section G): BIO-TECHNOLOGY GENERAL (ISRAEL) LTD.; pob 571, be'er tuvia industria; kiryat malachi,, 83104 ; IS 83104
• Manufacturer Contact: 100 interpace parkway; parsippany, NJ 07054 ; 9737961600
• MDR Report Key: 7328418
• MDR Text Key: 102070803
• Report Number: 3000164186-2018-00005
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• 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: 02/13/2018
• 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): Hospitalization