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U.S. Department of Health and Human Services

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

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE MOZ Back to Search Results
Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Arthralgia (2355); No Code Available (3191)
Event Type  malfunction  
Event Description
Device malfunction [device malfunction]. Lot of pain/ left knee with mostly medial jlt [joint tenderness]. Mild effusion [joint effusion]. Case narrative: this case is linked to case (b)(4) (same patient). Initial information received on 02/07/2019 regarding an unsolicited legal valid serious case received from a patient. This case involves a (b)(6) years old male patient (185. 395 cm and (b)(6) kg) who experienced lot of pain/ left knee with mostly medial jlt and mild effusion, while he had treated with hylan g-f 20, sodium hyaluronate (synvisc one). Also, device malfunction was identified for the reported lot number. The patient's past medical history included atrial fibrillation, prostate cancer in 2004, aortic valve replacement in (b)(6)-2008, thyroidectomy in 1973, retinopexy, nasal polyps, alcohol use, lactose intolerance with diarrhea and abdominal pain, rubber sensitivity on (b)(6)-2015, dermatitis contact, hematuria, bronchitis, prostatitis, chest pain, urinary tract infection, anemia, urinary tract obstruction, cough and asthenia. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing erectile dysfunction and hypersensitivity. Concomitant medications included paracetamol (tylenol); amlodipine besilate (norvasc); ciprofloxacin (cipro); doxycycline; diazepam (valium); fluticasone propionate (flonase) finasteride (proscar); levofloxacin (levaquin); levothyroxine sodium (synthroid); lorazepam (ativan); tamsulosin hydrochloride (flomax); prednisone; and warfarin sodium (coumadin), acetylsalicylic acid (aspirin), celecoxib (celexa). Olopatadine hydrochloride (pataday), cyanocobalamin (vitamin b12). On (b)(6)2017, the patient started taking synvisc one (hylan g-f 20, sodium hyaluronate), injection, 48 mg once via intra-articular route (lot - 7rsl021) for osteoarthritis and arthritis. On the next day, the patient developed a non-serious lot of pain/ left knee with mostly medial jlt (arthralgia) <> following the first dose intake of hylan g-f 20 and sodium hyaluronate. On an unknown date, the patient developed a non-serious mild effusion (joint effusion) following the first dose intake of hylan g-f 20 and sodium hyaluronate. Also, device malfunction was identified for the reported lot number of hylan g-f 20 and sodium hyaluronate. Relevant laboratory test results included: x-ray limb - on an unknown date: [minor loss of medial compartment joint space. The joints are otherwise well aligned. ] final diagnosis was severe lot of pain/ left knee with mostly medial jlt, mild effusion and device malfunction. It was not reported if the patient received a corrective treatment. Outcome- unknown for all events. An investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Seriousness criteria- medically significant for device malfunction.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8352559
MDR Text Key140291818
Report Number2246315-2019-00063
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number7RSL021
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: 02/19/2019 Patient Sequence Number: 1
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