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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 Dyspnea (1816); Joint Dislocation (2374); No Code Available (3191)
Event Type  Injury  
Event Description
Mass on the back [mass]. Bronchial issues [bronchial disorder]. Trouble with breathing really bad/ hurting breathing on the right hand side and starting on the left [difficulty breathing]. Pressure on the lung [chest pressure]. Surgeon has to realign the ribs [dislocation of rib]. Surgeon has to fix the spine where it has turned [spinal disorder]. Case narrative: initial information received on 27-mar-2020 regarding an unsolicited valid serious case received from patient via health authorities of united states under reference mw5092605. This case involves a male patient of unknown age, who developed mass on the back, bronchial issues, trouble with breathing really bad/ hurting breathing on the right hand side and starting on the left, pressure on the lung, surgeon has to realign the ribs and surgeon has to fix the spine where it has turned, while he using with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc) and steroid shots (unspecified). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In an unknown date in 2017 (3 injections 3 years ago), the patient started using hylan g-f 20, sodium hyaluronate injection 16mg/ 2 ml dosage (frequency, lot: unknown) for pain. There will be no information on the batch number for this case. On an unknown date over two years ago, a mass started appearing a little on the back and had continuously gotten bigger. Two and a half years ago, patient went and talked to the doctor, who said they needed to remove it, but then his daughter got ill, so he put it on hold. The patient continued to get the shots (unspecified) in his knees to help with the pain. The mass continued to get bigger. He went back to the surgeon again, who said it had to come out, but did a ct scan to make sure what we they were dealing with. After looking at the scan the doctor said that it just the way he was made and that there was nothing he could do or needed to. Since an unknown date, the patient had been having trouble with breathing bad and had bronchial issues. His doctor sent him to another surgeon, who looked at the ct scan and said it had to come out because it was putting pressure on the lung. So then, they transferred him to a lung specialist who agreed and added that this was hurting his breathing on the right-hand side and was starting on the left. On (b)(6) 2020, patient went to see the orthopedic doctor and got steroid shots in his knees. The patient questioned him if it was possible that the shots could be causing the mass on his back to keep growing, but the doctor had no idea that it was possible or not. But the patient had found articles online by different people who had wrote that they had the same issue. The patient just wanted to know if it was true, could it be what caused this. The patient was facing surgery to have the mass removed and at the same time, an orthopedic surgeon would have to be there to realign the ribs and to fix his spine where it had turned. It is a very major surgery with a very long recovery and reported that this really had a negative effect on his life. It was also reported that they had not done any kind of a biopsy or a draw on this to find out whether it was that chemical. Action taken: unknown for all the events. Corrective treatment: surgery was scheduled for all the events. Outcome: unknown for all the events. Seriousness criteria: life-threatening, disability/ permanent damage, medically significant for all the events. A product technical complaint (ptc) was initiated on (b)(6) 2020 for synvisc. Batch number: unknown; global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformation prior to release. Any out of specification result is identified and mitigated through the ncr process. Sanofi global pharmacovigilance and epidemiology continuously monitors adverse event reports with or without lot numbers and assesses possible associations with their corresponding product lot, as part of routine surveillance effort to detect safety signals. This review did not indicate any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Investigation complete date: (b)(6) 2020. Additional information was received on 10-apr-2020 from other healthcare professional (b)(4). Global ptc number and its results were added. Clinical course updated. Text amended accordingly.
 
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Brand NameSYNVISC
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
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key9980835
MDR Text Key194028006
Report Number2246315-2020-00057
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
Type of Report Initial
Report Date 04/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? 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: 04/21/2020 Patient Sequence Number: 1
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