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U.S. Department of Health and Human Services

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

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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 Cramp(s) (2193); Arthralgia (2355); Ambulation Difficulties (2544)
Event Date 05/21/2017
Event Type  Injury  
Event Description
Pain in left knee has increased [arthralgia] terrible cramping in my calf down to the tips of my toes [muscle spasms] can not walk without aid [gait disturbance] joint pain (never felt before) in my hands [arthralgia] joint pain (never felt before) in my lower back [back pain] this serious, regulatory authority, spontaneous report was received from a consumer in united states. This report concerns a patient of unknown age and gender who experienced pain in left knee has increased, terrible cramping in my calf down to the tips of my toes, can not walk without aid, joint pain (never felt before) in my hands, and joint pain (never felt before) in my lower back during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection of unknown dose, for osteoarthritis on unknown dates. The patient reported that they have received 2 of 3 injections of euflexxa. The injections were administered by their orthopedic surgeon. The patient reported that the injections were given in their left knee and they know their surgeon injected it properly. They reported they did not expect to get instant relief; however, the pain in their left knee has increased to a point where they cannot walk without aid. There was terrible cramping in their calf down to the tips of their toes. They have also experienced joint pain (never before felt) in their hands and lower back since receiving the 2nd injection. The patient reported they had previously (6 months ago) received 3 injections of hyalgan which did not present any of the above mentioned effects. Action taken with euflexxa was dose withdrawn. At the time of this report, the outcome of the events was not recovered. The patient`s past drug therapy was significant for hyalgan (from (b)(6) 2016 to unknown stop date). The following concomitant medication was reported: tramadol, mobic, multivitamin, vitamin b12, biotin, omega 3. 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
=
mw5069994. 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 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. (b)(4).
 
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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
83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
9737967600
MDR Report Key6710374
MDR Text Key79932754
Report Number3000164186-2017-00017
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 06/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2017
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/12/2017
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: 07/13/2017 Patient Sequence Number: 1
Treatment
BIOTIN; MOBIC; MULTIVITAMIN; OMEGA 3; TRAMADOL; VITAMIN B12
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