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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Fever (1858); Swelling (2091); Urinary Tract Infection (2120); Chills (2191); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 11/04/2017
Event Type  Injury  
Event Description
Immobilized; walking difficulty [mobility decreased], septic arthritis of right knee [arthritis septic], adverse event nos [adverse event nos], moderate ecchymosis left knee [ecchymosis injection site], total bilirubin increased [bilirubin increased], red blood cell count decreased [red blood cell count decreased], mean corpuscular volume increased [mean corpuscular volume increased], mean cell hemoglobin increased [mean cell hemoglobin increased], neutrophil percentage increased [neutrophil percentage increased], lymphocyte percentage decreased [lymphocyte percentage decreased], lymphocyte count decreased [lymphocyte count decreased], platelet count decreased [platelet count decreased], serum potassium decreased [serum potassium decreased], blood urea nitrogen increased [blood urea nitrogen increased], edema right knee [edema knees], stress right knee [stiff knees], knee effusion [effusion (r) knee], pain in right knee [pain in knee], swelling in right knee [swelling of r knee]. Case narrative: based on the information received on 11-sep-2018 the case became medically confirmed. Upon internal review on 11-sep-2018 the case upgraded from non-valid to valid as new events were added. Initial information received on 09-aug-2018 and 15-aug-2018 was processed together regarding an unsolicited serious legal case from united states received from a consumer. This case involves a (b)(6) male patient who experienced septic arthritis of right knee, adverse event nos, immobilized, moderate ecchymosis left knee, pain in right knee, swelling in right knee, edema right knee, stress right knee and knee effusion (latency: unknown), total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased (latency: 3 days) while he was treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The past medical history included arthritis on (b)(6) 2017, atrial fibrillation on (b)(6) 2017, heart rate abnormal, hypertension, spinal column stenosis, hypoacusis, peripheral swelling, cardiac pacemaker insertion with surgical history, hypersensitivity with codeine, cardiac failure on (b)(6) 2017, sleep apnoea syndrome on (b)(6) 2017, gastrooesophageal reflux disease on (b)(6) 2017, seizure, migraine, back problems, kidney stone, nephrolithiasis and arthritis. The patient's concurrent conditions included at the time of the event, the patient had ongoing tendonitis in 2018. The was a non-tobacco user and abstained from alcohol at the time of this report. Surgical history included cholecystectomy (gall bladder removed), patellectomy, appendicectomy, rotator cuff repair, knee arthroplasty, orthopedic surgeries. The past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included meloxicam (meloxicam); amlodipine besylate (amlodipine besylate); aspirin acetylsalicylic acid] (aspirin); ondansetron, piperacillin sodium, tazobactam sodium (zosyn), cyanocobalamin (cyanocobalamin); fish oil (omega 3 fish oils); rivaroxaban (rivaroxaban); trazodone hcl (trazodone hcl); levetiracetam (levetiracetam); calcium carbonate, cholecalciferol (calcium carbonate with d3); ubidecarenone (ubidecarenone); ezetimibe (ezetimibe); primidone (primidone); methocarbamol (methocarbamol); spironolactone (spironolactone); valsartan (valsartan); omeprazole (prilosec), bisoprolol fumarate (bisoprolol fumarate); furosemide (furosemide); clonazepam (clonazepam); glycopyrrolate (glycopyrrolate); oxycodone (oxycodone); betacarotene, bioflavonoids, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (multivitamin & mineral); and hydrochlorothiazide (hydrochlorothiazide). On (b)(6) 2017, the patient received intra articular hylan g-f 20, sodium hyaluronate injection at an unknown dose once (lot - unknown) for arthritis. On an unknown date in 2017, the patient developed septic arthritis of right knee (arthritis bacterial). On (b)(6) "2018" after a latency of 3 days (b)(6). This event was leading to intervention. The patient was hospitalized for this event, adverse event nos, was immobilized (mobility decreased), had moderate ecchymosis left knee, pain in right knee (arthralgia), swelling in right knee (joint swelling), edema right knee (oedema peripheral), stress right knee (joint stiffness) and knee effusion (joint effusion). On (b)(6) 2017, relevant laboratory test results included (b)(6). On (b)(6) 2017 labs included: blood glucose 134 mg/dl [high], carbon dioxide increased 32 mg/dl [high]; mean cell haemoglobin 34. 6 pg [high]. On (b)(6) 2017, labs were (b)(6); on (b)(6)2017, labs were (b)(6). The patient was put on 6-week iv antibiotic therapy. A surgery was performed to correct septic arthritis. The patient was using a rolling walker for ambulation. On (b)(6) 2017, the patient reported no falls, good appetite and normal bowel movements. The surgical wound was dressed on regular basis. The patient tolerated the whole procedure well. Final diagnosis was knee effusion, swelling in right knee, pain in right knee, adverse event nos, septic arthritis of right knee, immobilized, stress right knee, edema right knee and moderate ecchymosis left knee. Corrective: vancomycin (vancomycin) for arthritis bacterial and ceftriaxone (ceftriaxone) and surgical procedure for arthritis bacterial. Use of rolling walker for immobilized; walking difficulty outcome: not recovered for total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased; unknown for all events. Seriousness criteria: hospitalization and intervention required for arthritis bacteria; disability for mobility decreased. A product technical complaint (ptc) was initiated on 22-aug-2018 for synvisc. Batch number unknown, global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. All finished batch records for specification conformance prior to release were reviewed as per the requirement. Any out of specification result need to be identified and mitigated through the ncr process. Adverse event reports with or without lot numbers were continuously monitored by sanofi global pharmacovigilance and epidemiology and possible associations with their corresponding product lot were assessed as part of routine safety surveillance effort to detect safety signals. Final investigation complete date was 22-aug-2018. No safety issues were indicated in this review. Additional information was received on 22-aug-2018 in the form of investigation summary. Ptc results and number were added. Additional information was received on 11-sep-2018 from healthcare professional. Events of total bilirubin increased, red blood cell count decreased, mean corpuscular volume increased, mean cell hemoglobin increased, neutrophil percentage increased, lymphocyte percentage decreased, lymphocyte count decreased, platelet count decreased, serum potassium decreased and blood urea nitrogen increased was added. Medical history and concomitant medication was added. Clinical course was updated and text amended accordingly.
 
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Brand NameSYNVISC
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
MDR Report Key7915532
MDR Text Key121925685
Report Number2246315-2018-00577
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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: 09/27/2018 Patient Sequence Number: 1
Treatment
AMLODIPINE BESYLATE (AMLODIPINE BESYLATE),UNKNOWN; ASPIRIN [ACETYLSALICYLIC ACID],UNKNOWN; BISOPROLOL FUMARATE (BISOPROLOL FUMARATE),UNKNOWN; CALCIUM CARBONATE WITH D3,UNKNOWN; CLONAZEPAM (CLONAZEPAM),UNKNOWN; CYANOCOBALAMIN (CYANOCOBALAMIN),UNKNOWN; EZETIMIBE (EZETIMIBE),UNKNOWN; FUROSEMIDE (FUROSEMIDE),UNKNOWN; GLYCOPYRROLATE [GLYCOPYRRONIUM BROMIDE],UNKNOWN; HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE),UNKNOWN; LEVETIRACETAM (LEVETIRACETAM),UNKNOWN; MELOXICAM (MELOXICAM),UNKNOWN; METHOCARBAMOL (METHOCARBAMOL),UNKNOWN; MULTIVITAMIN & MINERAL,UNKNOWN; OMEGA 3 FISH OILS (FISH OIL),UNKNOWN; ONDANSETRON (ONDANSETRON),; OXYCODONE (OXYCODONE),UNKNOWN; PRILOSEC [OMEPRAZOLE] (OMEPRAZOLE),CAPSULE; PRIMIDONE (PRIMIDONE),UNKNOWN; RIVAROXABAN (RIVAROXABAN),UNKNOWN; SPIRONOLACTONE (SPIRONOLACTONE),UNKNOWN; TRAZODONE HCL (TRAZODONE HCL),UNKNOWN; UBIDECARENONE (UBIDECARENONE),UNKNOWN; VALSARTAN (VALSARTAN),UNKNOWN; ZOSYN (PIPERACILLIN SODIUM, TAZOBACTAM SODIUM),
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