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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Cellulitis (1768); Edema (1820); Erythema (1840); Fever (1858); Inflammation (1932); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091); Arthralgia (2355); Joint Swelling (2356); Abdominal Distention (2601); Weight Changes (2607)
Event Date 01/02/2017
Event Type  Injury  
Event Description
Lymphedema (described as rash, itching redness, and swelling). Abdomen is distended. Cellulitis of my legs (lower legs) due to an infection from the injection. Inflammation. Hardness down to feet [induration]. Feet swollen/ swelling from her feet to her knees [peripheral swelling]. Having a slight fever [pyrexia]. Hotness in the legs [feeling hot]. Gained 25 lbs [weight increased]. My life has been ruined [impaired quality of life]. Would be working if this had not happened [impaired work ability]. This serious, spontaneous report was received from a consumer in the united states. Case was upgraded to serious upon receipt of follow up on (b)(4) 2017 from a regulatory authority. This report concerns a (b)(6) year-old female who experienced lymphedema (described as rash, itching redness, and swelling), abdomen is distended, cellulitis of my legs (lower legs) due to an infection from the injection, inflammation, hardness down to feet, feet swollen/ swelling from her feet to her knees, having a slight fever, hotness in the legs, gained 25 lbs, my life has been ruined, would be working if this had not happened, legs are weaker, redness from her feet to knees, ankles swollen, ankles hurt and feet hurt, and the girl who administered hit my bone during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection (product concentration and dose not reported) weekly for osteoarthritis of the knees from (b)(6) 2017 to (b)(6) 2017. According to the patient, she began weekly injections with euflexxa and after the third injection, on an unknown date in (b)(6) 2017, she began to experience inflammation, hardness down to feet, feet swollen, redness from her feet to knees, ankles swollen, ankles hurt, feet hurt, swelling from her feet to knees, hotness in the legs, and having a slight fever. These events were reported to the physician on (b)(6) 2017. The patient had gone to a cardiologist and dermatologist due to the events (treatment, if any, was not reported). Physical therapy was not required. The patient also stated that she was diagnosed with cellulitis of the legs (lower legs) and the physician said that this was due to an infection from the injection. The patient also reported she developed a breakout of rash, itching redness, and swelling in (b)(6) 2017. The patient went to a dermatologist who could not explain the cause of her symptoms. She was finally diagnosed with lymphedema by an infectious disease doctor and she will soon start treatment. She also reported that her legs were weaker. The patient reported that she found information online that suggests her symptoms were caused by euflexxa. She did not know if this was from euflexxa or from the person who gave it to her. The girl who administered euflexxa hit her bone and she experienced redness right after it. She was also not told that she should not bear weight for too long for 48 hours. The patient gained 25 pounds since then and her abdomen is distended. The patient reported that the acids in the euflexxa contributed for the rash to appear and she is seeing a dermatologist. She also reported that her life has been ruined since receiving euflexxa and she has been to doctors ever since and has had no luck. The patient reported she would be working if this had not happened. Action taken with euflexxa was dose not changed. The outcome of lymphedema (described as breakout of rash, itching redness, and swelling), abdomen is distended, hardness down to feet, feet swollen, ankles swollen, ankles hurt, feet hurt, and swelling from her feet to knees was recovering. The outcome of hotness in the legs, having a slight fever, inflammation, legs are weaker, redness from her feet to knees, cellulitis of my legs (lower legs) due to an infection from the injection, gained 25 lbs, my life has been ruined, and would be working if this had not happened was not recovered. The outcome of the girl who administered hit my bone was unknown. The following concomitant medications were reported: synthroid, an unspecified cholesterol medication, multivitamin, aspirin, and voltaren (all from an unknown start dates to unknown stop dates). Medical history included past use of euflexxa two years ago. The patient did not have a history of knee surgery, obesity, rheumatoid arthritis, or smoking. It was unknown whether she had a history of chronic pain, regular exercise, allergies, or alcohol use. At the time of reporting, the case outcome was not recovered. Additional information received on 17-mar-2017 - follow up 01: the patient's weight was changed, the action taken with euflexxa was amended and stop date was added, the onset date of the adverse events was provided, and additional adverse events were reported (hotness in the legs and having a slight fever). Narrative and fields updated. Additional information received on 23-mar-2017 - follow up 02: this case was medically confirmed. The physician provided medical history, additional concomitant medications, date, lot number, and expiration date for each of the three euflexxa injections, and outcome and causality of events. Narrative and fields updated. Additional information received on 19-jun-2017 - follow up 03: this case was upgraded to a serious case due to the event of cellulitis. Outcome of events was updated and additional adverse events were added (cellulitis, drug administration error, and weight increased). Narrative and fields updated. 28-jun-2017: during safety review it was assessed that this case is not serious. Additional information received on 23-jun-2017 and 06-jul-2017 - follow up 04: case was upgraded to serious due to information received from fda on (b)(6) 2017 with event of lymphedema. Event of lymphedema and abdominal distention added. Product route updated. Action taken updated. Narrative updated. Additional information received on 28-jul-2017 and 02-aug-2017 from the consumer- follow up 05: additional events of impaired quality of life, inability to work, and muscular weakness were added. Narrative updated. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: case number, others
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(b)(4). 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 (b)(6) country and did not result in a corrective action by the manufacturer no corrective action was done by the manufacturer or requested by regulators. Argus number: (b)(4).
 
Event Description
Lymphedema (described as rash, itching redness, and swelling) [lymphoedema], abdomen is distended [abdominal distension], cellulitis of my legs (lower legs) due to an infection from the injection [cellulitis], inflammation [inflammation], hardness down to feet [induration], feet swollen/ swelling from her feet to her knees [peripheral swelling], having a slight fever [pyrexia], hotness in the legs [feeling hot], gained 25 lbs [weight increased], redness from her feet to knees [erythema], ankles swollen [joint swelling], ankles hurt [arthralgia], feet hurt [pain in extremity], the girl who administered hit my bone [wrong technique in product usage process]. This serious, spontaneous report was received from a consumer in the united states. Case was upgraded to serious upon receipt of follow up on 06-jul-2017 from a regulatory authority. This report concerns a (b)(6) female who experienced lymphedema (described as breakout of rash, itching redness, and swelling), abdomen is distended, inflammation, hardness down to feet, feet swollen, redness from her feet to knees, ankles swollen, ankles hurt, feet hurt, swelling from her feet to knees, hotness in the legs, having a slight fever, cellulitis of my legs (lower legs) due to an infection from the injection, the girl who administered hit my bone, and gained 25 lbs during treatment with intra-articular euflexxa (sodium hyaluronate) solution for injection (product concentration and dose not reported) weekly for osteoarthritis of the knees from (b)(6) 2017. According to the patient, she began weekly injections with euflexxa and after the third injection, on an unknown date in (b)(6) 2017, she began to experience inflammation, hardness down to feet, feet swollen, redness from her feet to knees, ankles swollen, ankles hurt, feet hurt, swelling from her feet to knees, hotness in the legs, and having a slight fever. These events were reported to the physician on (b)(6) 2017. The patient had gone to a cardiologist and dermatologist due to the events (treatment, if any, was not reported). Physical therapy was not required. The patient also stated that she was diagnosed with cellulitis of the legs (lower legs) and the physician said that this was due to an infection from the injection. The patient also reported she developed a breakout of rash, itching redness, and swelling in (b)(6) 2017. The patient went to a dermatologist who could not explain the cause of her symptoms. She was finally diagnosed with lymphedema by an infectious disease doctor and she will soon start treatment. The patient reported that she found information online that suggests her symptoms were caused by euflexxa. She did not know if this was from euflexxa or from the person who gave it to her. The girl who administered euflexxa hit her bone and she experienced redness right after it. She was also not told that she should not bear weight for too long for 48 hours. The patient gained 25 pounds since then and her abdomen is distended. The patient reported that the acids in the euflexxa contributed for the rash to appear and she is seeing a dermatologist. She stated that she still had these problems. Action taken with euflexxa was dose not changed. The outcome of lymphedema (described as breakout of rash, itching redness, and swelling), abdomen is distended, hardness down to feet, feet swollen, ankles swollen, ankles hurt, feet hurt, and swelling from her feet to knees was recovering. The outcome of hotness in the legs, having a slight fever, inflammation, redness from her feet to knees, cellulitis of my legs (lower legs) due to an infection from the injection, and gained 25 lbs was not recovered. The outcome of the girl who administered hit my bone was unknown. The following concomitant medications were reported: synthroid, an unspecified cholesterol medication, multivitamin, aspirin, and voltaren (all from an unknown start dates to unknown stop dates). Medical history included past use of euflexxa two years ago. The patient did not have a history of knee surgery, obesity, rheumatoid arthritis, or smoking. It was unknown whether she had a history of chronic pain, regular exercise, allergies, or alcohol use. At the time of reporting, the case outcome was not recovered. Additional information received on 17-mar-2017 - follow up 01: the patient's weight was changed, the action taken with euflexxa was amended and stop date was added, the onset date of the adverse events was provided, and additional adverse events were reported (hotness in the legs and having a slight fever). Narrative and fields updated. Additional information received on 23-mar-2017 - follow up 02: this case was medically confirmed. The physician provided medical history, additional concomitant medications, date, lot number, and expiration date for each of the three euflexxa injections, and outcome and causality of events. Narrative and fields updated. Additional information received on 19-jun-2017 - follow up 03: this case was upgraded to a serious case due to the event of cellulitis. Outcome of events was updated and additional adverse events were added (cellulitis, drug administration error, and weight increased). Narrative and fields updated. On 28-jun-2017: during safety review it was assessed that this case is not serious. Additional information received on 23-jun-2017 and 06-jul-2017 - follow up 04: case was upgraded to serious due to information received from fda on 06-jul-2017 with event of lymphedema. Event of lymphedema and abdominal distention added. Product route updated. Action taken updated. Narrative updated. Overall listedness (core label) is unlisted. Reporter causality: related. Company causality: related. Other case numbers: case number, others
=
(b)(4), mw5070600. 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. Argus number: (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
kiryat malachi, 83104
IS 83104
Manufacturer Contact
100 interpace parkway
parsippany, NJ 07054
9737967600
MDR Report Key6722177
MDR Text Key210370132
Report Number3000164186-2017-00021
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
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 Received07/28/2017
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: 07/18/2017 Patient Sequence Number: 1
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