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

Catalog Number 6391182010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Pain (1994); Arthralgia (2355)

Event Date 12/01/2018

Event Type  Injury  

Event Description

Breathing issues (respiration abnormal).Unbearable pain in both knees (arthralgia).The last series of injections did not work (device ineffective).Case (b)(4) is a serious spontaneous complaint case received from a consumer in united states.This report concerns a (b)(6) year-old female who experienced breathing issues, unbearable pain in both knees and her last series of three injections did not work during treatment with intra-articular euflexxa (sodium hyaluronate) given as solution for injection with unknown concentration, weekly for three weeks and for osteoarthritis (b)(6) 2018.The patient reported that she had used euflexxa for two years with good results.The patient received her last series of three injections in (b)(6) 2018 and experienced unbearable pain in both knees in (b)(6) 2018 and reported that the last series of injections did not work for the six months like they had in the past.The patient stated that she was hospitalized overnight for breathing issues in (b)(6) 2018 and had a procedure with iodine to rule out a blood clot in the lung, the results were negative.No additional information was provided.Action taken with euflexxa was not applicable.At the time of this report, the outcome of breathing issues was recovered.The outcome of unbearable pain in both knees and the last series of injections did not work were not recovered.The patient`s medical history was significant for asthma.The patient`s procedures included medical procedure with iodine.Concomitant medication was not reported.The event breathing issues was reported as serious.The events unbearable pain in both knees and the last series of injections did not work were reported as non-serious.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related.Other case numbers: case number, others = (b)(4).Case number, complaint= (b)(4).This ae occurred in united states 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 (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.

Event Description

Breathing issues [respiration abnormal].Unbearable pain in both knees [arthralgia].The last series of injections did not work [device ineffective].Case (b)(4) is a serious spontaneous complaint case received from a consumer in united states.This report concerns a 64-year-old female who experienced breathing issues, unbearable pain in both knees and her last series of three injections did not work during treatment with intra-articular euflexxa (sodium hyaluronate).Euflexxa was given as solution for injection with unknown concentration, weekly for three weeks and for osteoarthritis from (b)(6) 2018 to (b)(6) 2018.The patient reported that she had used euflexxa for two years with good results.The patient received her last series of three injections in (b)(6) 2018 and experienced unbearable pain in both knees in (b)(6) 2018.Also, the patient reported that the last series of injections did not work for the six months like they had in the past.The patient stated that she was hospitalized overnight for breathing issues in (b)(6) 2018, and had a procedure with iodine to rule out a blood clot in the lung, the results were negative.The patient's physician reported they did not see the patient in the office for reported issues but the patient did call and speak with the physician assistant (pa) and felt her knee pain was worse.No additional information was provided.The patient`s medical history was significant for asthma, obesity, non smoker, alcohol use, x-rays and physical examination of knee.The patient`s procedures included medical procedure with iodine and partial medial/lateral meniscectomy.Concomitant medication was not reported.Action taken with euflexxa was not applicable.At the time of this report, the outcome of breathing issues was recovered.The outcome of unbearable pain in both knees and the last series of injections did not work were not recovered.The event breathing issues was reported as serious.The events unbearable pain in both knees and the last series of injections did not work were reported as non-serious.The event breathing issues was not related, and the events unbearable pain in both knees and the last series of injections did not work were related.At the time of reporting the case outcome was not recovered.Overall listedness (core label) is unlisted.Reporter causality: related.Company causality: related: knee pain.Not related: breathing issues.Other case numbers: internal # - others = (b)(4).Internal # - complaint = (b)(4).Internal # - complaint = (b)(4).Fda device report number # = initial report.Fda device report number # = 3000164-2019-00002.This ae occurred in united states 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.Additional information received on 26-mar-2019 from physician: follow-up 01: medically confirmed event of knee pain.Injection dates of (b)(6) were reported.Patient medical history, labs and procedures were provided.Case fields and narrative updated accordingly.

• 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
• MDR Report Key: 8235964
• MDR Text Key: 132916290
• Report Number: 3000164186-2019-00001
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6391182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 109