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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC MOZ Back to Search Results
Lot Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nausea (1970); Blurred Vision (2137); Vomiting (2144); Arthralgia (2355)
Event Type  Injury  
Event Description
Blood in stool [blood in stool]; knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation [knee pain]; osteophytosis of all compartments/small supra and infrapatellar spurs [exostosis]; arthritic, statistically primary changes right knee [knee arthritis]; multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [degenerative disc disease]; multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses [vertebral foraminal stenosis]; muscle spasm [muscle spasm]; weakness [weakness]; poor appetite [decreased appetite]; insomnia [insomnia] ; blurry vision [blurry vision]; loss of hearing [hearing impaired] ; recurrent urinary infections [recurrent urinary tract infection] ; bronchitis [bronchitis] ; chest pain [chest pain] ; hypertension [hypertension]; acid reflux [acid reflux (esophageal)] ; nausea [nausea] ; vomiting [vomiting] ; constipation [constipation] ; both knee deformity [knee deformity] ; right knee crepitus [joint crepitation] ; synvisc administered intramuscularly [device use issue]. Case narrative: initial information received on 03-apr-2019 regarding a solicited valid serious case received from a physician, in the scope of patient support program "(b)(4)". Patient id: (b)(6); country: united states. Study title: (b)(6). This case involves a (b)(6) years old male patient who was treated medical device hylan g-f 20, sodium hyaluronate (synvisc) and experienced blood in stool, knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation, osteophytosis of all compartments/small supra and infrapatellar spurs, arthritic, statistically primary changes right knee, multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses, muscle spasm, weakness, poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, constipation, both knee deformity, right knee crepitus (latency: unknown) and synvisc was administered intramuscularly (device use issue). The patient's past medical history included left knee replacement, abdomen surgery, knee arthroscopy, work related injury 11 years ago and oral surgery. The patient's family history included mother died due to heart attack and had arthritis, depression, diabetes mellitus, hypertension and high cholesterol. The patient's past medical treatment(s), vaccination(s) was not provided. At the time of the event, the patient had ongoing chronic low back pain which was aggravated by walking, cold weather, physical activity and standing, lumbar radiculopathy, sacroiliac joint pain for which patient had sij injection with few days of pain relief, bilateral, sleep apnoea syndrome, obesity, numbness/tingling, migraine, diabetes mellitus, depression, had long term opioid therapy and asthma. Concomitant medications included bupropion hydrochloride (bupropion hcl er), cyclobenzaprine hcl, hydrochlorothiazide, salbutamol sulfate (ventolin hfa). On an unknown date, the patient started using hylan g-f 20, sodium hyaluronate via intramuscular route (formulation, lot - unknown) for unknown indication. On (b)(6) 2018, x-ray showed mild osteophytosis of all compartments and small supra and infrapatellar spurs, arthritic statistically primary changes right knee. There was no acute fracture, dislocation or neoplastic process. Soft tissues were unremarkable. On an unknown date patient was diagnosed with bilateral knee pain and was injected with bupivacaine and dexamethasone. On 12-mar-2019, it was reported that l-spine magnetic resonance imaging showed multilevel degenerative changes of disc and facet joints with moderate lateral recess and foraminal stenoses and no central canal stenosis. Patient also reported he had no issues with the knees and had low back pain irradiating to lower extremity to the feet. The review of symptoms showed poor appetite, insomnia, blurry vision, loss of hearing, recurrent urinary infections, bronchitis, chest pain, hypertension, acid reflux, nausea, vomiting, blood i stool, constipation. Patient had tenderness to palpitation, deformity in both knees and crepitus in right knee. The therapy with hylan g-f 20, sodium hyaluronate was reported as ongoing. Action taken: no action taken. Corrective treatment: dexamethasone and bupivacaine for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation; not reported for rest. Outcome: unknown for all except synvisc was administered intramuscularly. A product technical complaint was initiated and results were pending for the same. Seriousness criteria: medically significant for blood in stools, intervention required for knee pain bilateral/pain described as dull achy, sharp, burning and throbbing in nature/tenderness with palpitation. Reporter causality: unassessable (unknown) for all. Company causality: not reportable for all.
 
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Brand NameSYNVISC
Type of DeviceMOZ
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8542671
MDR Text Key142899993
Report Number2246315-2019-00126
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Type of Report Initial,Followup,Followup
Report Date 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/24/2019 Patient Sequence Number: 1
Treatment
BUPROPION HCL ER (BUPROPION HYDROCHLORIDE),TABLET; CYCLOBENZAPRINE HCL (CYCLOBENZAPRINE HCL),TABLET; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE),TABLET; VENTOLIN HFA,INHALATION VAPOUR, SOLUTION
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