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

Catalog Number 6301182010

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

Walking with cane now for 8 months [gait disturbance].Severe pain minutes after injections [pain].Got all three euflexxa injections at the same time [inappropriate schedule of product administration].Case (b)(4) is a serious spontaneous case received from a consumer in united states.This report concerns a male patient of unknown age, who experienced has been walking with cane now for 8 months (walking difficulty), severe pain minutes after injections, and got all three euflexxa injections at the same time (inappropriate schedule of product administration) during treatment with euflexxa (sodium hyaluronate) solution for injection, 3 injections at once, for unknown indication from an unknown start date and unknown if ongoing.The patient's friend reported that the patient got all three injections of euflexxa at the same time and that since then he had issues, severe pain minutes after injections and had been walking with a cane for eight months.The friend stated that the patient had been seeing doctors for this and did not want to share any additional information as the patient was unaware that he was calling.No additional information was provided.Action taken with euflexxa was not applicable.At the time of this report, the outcome of severe pain minutes after injections and got all three euflexxa injections at the same time were unknown and the outcome of has been walking with cane now for 8 months was not recovered.Concomitant medication and medical history were not reported.The event walking with cane now for 8 months was reported as serious.The events severe pain minutes after injections, got all three euflexxa injections at the same time 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: (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 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 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: 8860236
• MDR Text Key: 153836613
• Report Number: 3000164186-2019-00032
• 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: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 6301182010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability