• 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 Patient-Device Incompatibility (2682)
Patient Problems Cellulitis (1768); Edema (1820); Itching Sensation (1943); Pain (1994); Ambulation Difficulties (2544); Fluid Discharge (2686)
Event Date 12/12/2018
Event Type  Injury  
Event Description
Diagnosed with cellulitis of right leg (signs/symptoms of the definitive diagnosis);(cellulitis); hyperglycemia; groin pains; welling up to thigh, bilateral edema (oedema periphera). Case (b)(4) is a serious spontaneous case received from a consumer in united states. This report concerns a (b)(6) year-old male who was diagnosed with cellulitis of right leg (signs/symptoms of the definitive diagnosis), hyperglycemia, groin pain and bilateral edema during treatment with euflexxa (sodium hyaluronate) solution for injection unknown concentration, route and dose, for osteoarthritis from (b)(6). On (b)(6) 2018, the patient received his first injection of euflexxa in both knees. On (b)(6) 2018, the patient experienced severe pain in legs, swelling up to thigh, itching, leg was blood red, scratching which caused it to bleed, bumps on leg from the knee down and bumps leaking fluid. The patient could hardly walk and needed to walk with a walker. On an unspecified case in (b)(6) 2018 the patient also reported experiencing groin pain. On (b)(6) 2018, the patient went to the doctor and was diagnosed with cellulitis of right leg, bilateral edema and hyperglycemia and was given a cortisone injection and was prescribed vibramycin, prednisone, and clindamycin. The patient also had a bilateral leg ultrasound which showed normal arteries and veins. At the time of this report, the patient was going for edema therapy and was wearing stockings. Reportedly the edema goes down at night after wearing the stockings but reappears after getting up. No additional information was provided. Action taken with euflexxa was dose withdrawn. At the time of this report, the outcome of diagnosed with cellulitis of right leg (signs/symptoms of the definitive diagnosis), bilateral edema, and hyperglycemia were not recovered. The outcome of groin pain was unknown. Concomitant medication reported: unknown diabetes medication (injection). Medical history included drug allergy and caffeine allergy. Relevant laboratory values included: ultrasound scan: normal arteries and veins ni (normal), (b)(6) 2018. The event diagnosed with cellulitis of right leg [signs/symptoms of the definitive diagnosis], was reported as serious. The events hyperglycemia, groin pain, and bilateral edema 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: internal # - others
=
(b)(4). 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
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 Key8322604
MDR Text Key135768050
Report Number3000164186-2019-00006
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 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number6301182010
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 02/08/2019 Patient Sequence Number: 1
-
-