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

Catalog Number 6301182010

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

Patient Problems Muscle Spasm(s) (1966); Vomiting (2144); Cramp(s) (2193)

Event Date 03/29/2016

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Stroke [cerebrovascular accident]. Throwing up [vomiting]. Cramps in the right leg [muscle spasms]. Alternative to surgery for torn meniscus [off label use of device]. Case description: this serious spontaneous report was received from a consumer in united states. This report concerns a (b)(6) female who was diagnosed with a stroke and experienced throwing up, cramps in the right leg, and used as alternative to surgery for torn meniscus during treatment with euflexxa (sodium hyaluronate) solution for injection, weekly, for meniscus injury from (b)(6) 2016. It was reported that the patient received her first injection of euflexxa on (b)(6) 2016 in her right knee as an alternative to surgery for a torn meniscus. On (b)(6) 2016, she received her second injection. In the evening after the injection, she awoke, throwing up and with cramps in her right leg. In the morning, she went to work but around 11 am, she could not sign her name to a check. It was reported that at 1 pm on (b)(6) 2016 she was admitted into the hospital and was diagnosed with a stroke. The patient remained hospitalized through (b)(6) 2016. Treatment was not reported. The patient reported that she has trouble getting around and does not feel right. Action taken with euflexxa was dose withdrawn. On an unknown date, the outcome of throwing up, cramps in the right leg, and alternative to surgery for torn meniscus was unknown. The outcome of stroke was not recovered. The patient`s medical history was significant for stent placement in 2012. Concomitant medication use was not reported. At the time of reporting the case outcome was unknown. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: case number, others
=
(b)(4). 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.

• 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: 5700363
• MDR Text Key: 46580179
• Report Number: 3000164186-2016-00010
• 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
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 6301182010
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/24/2016
• 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 Treatment Data

Date Received: 06/06/2016 Patient Sequence Number: 1