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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Host-Tissue Reaction (1297); Autoimmune Disorder (1732); Contusion (1787); Pain (1994); Tingling (2171); Arthralgia (2355); Joint Swelling (2356); Paraplegia (2448)
Event Date 01/01/2017
Event Type  Injury  
Event Description
Frozen arms (paralysis in the arms) [monoplegia], developed a terrible systemic immune reaction to euflexxa [immune system disorder], tingling in the legs [paraesthesia], right ankle is bruised [contusion], crippling pain in the right knee/ pain in the left knee [arthralgia], right knee was hot [arthralgia], right knee was swollen [joint swelling], wrist started to swell [joint swelling], pain in her wrist [arthralgia], her arms were hurting so bad it was difficult to put her jacket on [pain in extremity], pain in her hand [pain in extremity]. This serious complaint, spontaneous report was received from a consumer in united states. This report concerns a (b)(6) female who experienced frozen arms (paralysis in the arms), developed a terrible systemic immune reaction to euflexxa, tingling in the legs, right ankle is bruised, crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, wrist started to swell, pain in her wrist, her arms were hurting so bad it was difficult to put her jacket on, and pain in her hand during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection 20 mg/ml, 20 mg/ml, weekly for 3 weeks (3 shots in both knees), for osteoarthritis from (b)(6) 2017. The patient stated that after the first injection, she had crippling pain in the right knee. The knee was hot and swollen. She experienced pain in the left knee as well but that was getting better and it was not as bad as the right knee. She also experienced tingling in the legs. On (b)(6) 2017, her wrist started to swell and she was experiencing pain in her wrist. Her arms were hurting so bad it was difficult to put her jacket on. The patient further explained the frozen arms as paralysis in the arms. Her physician prescribed her physical therapy to help gain movement back in her arms. The physician also gave her a cortisone injection to help with the symptoms. She was able to go to a couple physical therapy appointments, but due to lack of insurance she was no longer seeing her therapist. The patient reported that she was doing her own therapy at home in the swimming pool. Due to her therapy, she was now starting to get movement back in her arms. The patient stated that she was frustrated with everything going on so she was referred to a rheumatologist. The rheumatologist felt that she was experiencing an immune reaction to euflexxa. The patient also stated that her right ankle was bruised and she was experiencing pain in her hand that had improved since her injections. All of her symptoms were getting better as time had gone on. The frozen arms (paralysis in the arms) was medically significant. The systemic immune reaction was medically significant action taken with euflexxa was dose not changed. On an unknown date, the outcome of wrist started to swell, pain in her wrist, frozen arms (paralysis in the arms), developed a terrible systemic immune reaction to euflexxa, tingling in the legs, right ankle is bruised, crippling pain in the right knee/ pain in the left knee, right knee was hot, right knee was swollen, arms were hurting so bad it was difficult to put her jacket on, and pain in her hand was recovering/resolving. The patient's medical history was significant for sprained ankle 20 years ago (from 1997 to unknown stop date) and has twin girls (from unknown start date to unknown stop date) and allergy to sulfa (from unknown start date to unknown stop date) and broke her right wrist (from 1998 to unknown stop date). Concomitant medication was not reported. The following laboratory values were relevant: (b)(6). At the time of reporting the case outcome was recovering/resolving. This ae occurred in the united states 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. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: (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
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 Key6739993
MDR Text Key80913515
Report Number3000164186-2017-00025
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2017
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2017
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: 07/25/2017 Patient Sequence Number: 1
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