• 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 Device Operates Differently Than Expected (2913)
Patient Problems Erythema (1840); Fatigue (1849); Muscle Weakness (1967); Nausea (1970); Swelling (2091); Tachycardia (2095); Myalgia (2238); Arthralgia (2355); Malaise (2359); Palpitations (2467)
Event Date 11/08/2017
Event Type  Injury  
Event Description
Totally disabled [physical disability]; inability to walk for three to four days, reduced my ambulatory capacity [gait inability]; immediate swelling of the left calf muscle [muscle swelling]; muscle ache in the left forearm [myalgia]; flu-like symptoms [influenza like illness]; facial puffiness [swelling face]; racing heartbeat [palpitations]; pounding heartbeat [palpitations]; injections have made me ill [malaise]; joint pain including my left wrist [arthralgia]; fatigue [fatigue]; nausea [nausea]; knee pain [arthralgia]; red face [erythema]; joint pain on the left side of my body [arthralgia]. Case (b)(4) is a serious, spontaneous case received from a consumer via a regulatory authority in united states. This report concerns a patient of unknown age and gender who experienced an inability to walk for three to four days, reduced ambulatory capacity, was totally disabled, immediate swelling of the left calf muscle, muscle ache in the left forearm, flu-like symptoms, facial puffiness, racing heartbeat, pounding heartbeat, injections have made them ill, joint pain including their left wrist, fatigue, nausea, severe knee pain, red face and joint pain on the left side of their body during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 1 %, (dose unknown), weekly for 3 weeks, for osteoarthritis from 2017 to 2017. It was reported that the patient received their last injection of their euflexxa series on an unspecified date in (b)(6) 2017. The patient reported that each injection brought on multiple negative side effects. The patient experienced immediate swelling of the left calf muscle, joint pain on the left side of their body, up to and including their left wrist and muscle ache in the left forearm. They experienced an inability to walk for three to four days following each injection due to severe knee pain, nausea, fatigue, and flu-like symptoms. The patient also reported an extremely red face and facial puffiness that lasted approximately 15 minutes post injection. The patient experienced a racing and pounding heartbeat approximately five to ten minutes post injection that lasted about one to two hours. The patient reported that in summary the euflexxa injections have made them ill and have reduced their ambulatory capacity. The patient informed their physician of the side effects after their first injection but was not advised to discontinue the series of injections. The patient reported that they were advised that due to the injections, knee surgery could not even be discussed for two and a half to three months due to increased risk of infection. The patient reported that they remained totally disabled. The patient was disabled or suffered permanent damage due to their inability to walk for three to four days and reduction in ambulatory capacity. The patient was disabled or suffered permanent damage due to being totally disabled. Action taken with euflexxa was dose not changed. At the time of this report, the outcome of inability to walk for three to four days, reduced my ambulatory capacity was not recovered, the outcome of totally disabled was not recovered, the outcome of immediate swelling of the left calf muscle was unknown, the outcome of muscle ache in the left forearm was unknown, the outcome of flu-like symptoms was unknown, the outcome of facial puffiness was unknown, the outcome of injections have made me ill was unknown, the outcome of joint pain including my left wrist was unknown, the outcome of fatigue was unknown, the outcome of nausea was unknown, the outcome of knee pain was unknown, the outcome of red face was unknown, the outcome of joint pain on the left side of my body was unknown. In (b)(6) 2017, the outcome of racing heartbeat was recovered, the outcome of pounding heartbeat was recovered. The following concomitant medications were reported: cephalexin, robaxin, and benadryl. The events inability to walk for three to four days, reduced my ambulatory capacity, totally disabled were reported as serious. The events immediate swelling of the left calf muscle, muscle ache in the left forearm, flu-like symptoms, facial puffiness, racing heartbeat, pounding heartbeat, injections have made me ill, joint pain including my left wrist, fatigue, nausea, knee pain, red face, joint pain on the left side of my body 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
=
mw5073407. 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 regulators.
 
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.
pob 571, be'er tuvia industria
kiryat malachi,, 83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
9737961600
MDR Report Key7112892
MDR Text Key94729146
Report Number3000164186-2017-00036
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/13/2017 Patient Sequence Number: 1
Treatment
BENADRYL (DIPHENHYDRAMINE HYDROCHLORIDE); CEPHALEXIN (CEFALEXIN); ROBAXIN (METHOCARBAMOL)
-
-