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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 Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 12/07/2017
Event Type  Injury  
Event Description
Based on additional information received on 06-feb- 2018, this case initially considered as non-serious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site). This unsolicited case from united states was received on 02-jan-2018 from a patient. This case concerns a (b)(6) male patient who received treatment with synvisc one and later after unknown latency had difficulty ambulating/ walking less due to pain, losing sleep, more pain (latency 1 day) and had difficulty weight bearing, redness, warmth, increased swelling at site. Also, device malfunction was identified for the reported lot number. Relevant medical history included gastroesophageal reflux disease, heart disease. Relevant concurrent condition included hypertension. Relevant concomitant medication included dexlansoprazole (dexilant) foe gerd, amlodipine besilate (norvasc) as calcium blocker, paracetamol (tylenol) for pain/fever, cyclobenzaprine hydrochloride (flexeril) for muscle spasm, hydrochlorothiazide/valsartan (diovan hct) for hypertension. The patient was allergic to morphineanxiety, sweating. On (b)(6) 2017, patient's culture- gram/anaerobe showed no growth, synovial fluid analysis showed no crystals, <2 protein and cell count showed normal rbc 150 nucleated cells. It was reported that the patient consulted the healthcare professional by telephone and saw him in person on (b)(6) 2017. The patient did not visit the emergency room and was not admitted to the hospital. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection once (dose: 48 mg/6 ml) for pain in knee and osteoarthritis (lot number: 7rsloz1; expiration date: may-2020). On an unknown date in 2017, after unknown latency, the patient had difficulty ambulating. It was reported that the patient still had pain and difficulty ambulating and was walking "much less" due to the pain. On (b)(6) 2017, 01 day after initiating treatment with alemtuzumab, the patient experienced more pain, redness, warmth, pain, swelling, difficulty weight bearing. He had an appointment to follow up with his doctor on (b)(6) 2018. On an unknown date in 2017, the patient had increased swelling at the site. Since an unknown date in 2017, the patient had been losing sleep due to pain and worry about the infection. It was reported that the patient asked if infection can circulate through his system. He states the injection was placed into left knee and it was not measured before the injection. He stated that he did not feel he should have to pay for the injection or the follow up. He requested reimbursement. Action taken: permanently discontinued. Corrective treatment: knee aspiration, cortisone injection for difficulty weight bearing, redness, warmth, more pain, increased swelling at site; not reported for rest of the events. Outcome: unknown for losing sleep, difficulty ambulating/ walking less due to pain, device malfunction; not recovered/not resolved for difficulty ambulating/ walking less due to pain, more pain, warmth, redness, difficulty weight bearing, increased swelling at site (b)(4). 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. Additional information was received on 31-jan-2018. Global ptc number and ptc results were added. Clinical course updated. Text was amended accordingly. Additional information was received on 06-feb-2018 from the patient. This case initially considered as nonserious was upgraded to serious (required intervention for device malfunction, difficulty weight bearing, redness, warmth, more pain, increased swelling at site). Dosing details of the suspect product was updated (dates updated, lot number added, indication updated). Medical history, past drugs, concomitant medications and concurrent conditions were added. Clinical course was updated. Text was amended accordingly. Pharmacovigilance comment: sanofi company comment for follow up dated 06-feb-2018. This case concerns a patient who presented weight bearing difficulty and device malfunction after receiving treatment with synvisc one. Based upon the information, the causal role of the product cannot be denied with the occurrence of event. However, further detailed information regarding detailed medical history, lab data, concurrent conditions, concomitant medications and other risk factors would aid in the better assessment of the case.
 
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Brand NameSYNVISC ONE
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 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater, NJ 08807
9089817289
MDR Report Key7279799
MDR Text Key100547200
Report Number2246315-2018-00316
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P940015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2020
Device Lot Number7RSL021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/22/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2018 Patient Sequence Number: 1
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