• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIO-TECHNOLOGY GENERAL (ISRAEL) LTD EUFLEXXA 1% SODIUM HYALURONATE Back to Search Results
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 Action taken with euflexxa was dose withdrawn.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEUFLEXXA
Type of Device1% 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 Key5700363
MDR Text Key46580179
Report Number3000164186-2016-00010
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P010029
Number of Events Reported1
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 Received06/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number6301182010
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2016
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
-
-