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

Catalog Number 6301182010

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Nausea (1970); Malaise (2359); Palpitations (2467)

Event Date 01/01/2012

Event Type  Injury  

Event Description

Rapid heart rate [hear rate increased].Did not feel well [malaise].Felt odd [feeling abnormal].Felt nauseous [nausea].Received one injection every two weeks for 6 weeks [device used for unapproved schedule].Case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns a (b)(6) male who experienced rapid heart rate, did not feel well, felt odd, felt nauseous, and received one injection every two weeks for 6 weeks [device used for unapproved schedule] during treatment with euflexxa (sodium hyaluronate) solution for injection 20 mg, route of administration unknown, 20 mg, 1 injection into right knee for 6 weeks, every 2nd week, for osteoarthritis from 2012 to 2012.The reporter (patient's wife) stated that her husband received a series of three injections of euflexxa about six years ago (exact date unknown).The patient received one injection every two weeks for six weeks.Starting after the first injection, the patient experienced a rapid heart rate and went to the emergency room (er) where the rapid heart rate resolved on its own and he was discharged from the er.He just did not feel well, felt nauseous, and odd after receiving each injection.The event of rapid heart rate was medically significant.Action taken with euflexxa was dose not changed.On an unknown date, the outcome of did not feel well was recovered, the outcome of felt odd was recovered, the outcome of felt nauseous was recovered, the outcome of received one injection every two weeks for 6 weeks was recovered.In 2012, the outcome of rapid heart rate was recovered.The patient's medical history was significant for retinal detachment, bph, asthma and gerd (from unknown start date to unknown stop date).The following concomitant medications were reported: flomax, lipitor, and protonix.The event rapid heart rate was reported as serious.The events did not feel well, felt odd, felt nauseous, received one injection every two weeks for 6 weeks were reported as non-serious.At the time of reporting the case outcome was recovered.Overall listedness (core label) is unlisted.Reporter causality: related, company causality: not related.Other case numbers: link: same reporter = (b)(4).Case number, others = (b)(4).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 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 regulator.

• 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: 7490352
• MDR Text Key: 107467424
• Report Number: 3000164186-2018-00014
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• 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: 04/23/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLOMAX; LIPITOR; PROTONIX
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 104