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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Headache (1880); Myocardial Infarction (1969); Tachycardia (2095); Tingling (2171); Dizziness (2194); Numbness (2415)
Event Date 01/01/2020
Event Type  Injury  
Event Description
Fast heart beat such that she thought she was having a heart attack [heart attack] ([heart rate increased]), felt tired [tiredness], numbness and tingling in arm [numbness of upper arm], numbness and tingling in arm [tingling of extremity], headache [headache], dizziness [dizziness], received injection in shoulder (off label use) [off label use]. Case narrative: initial information from united states received on 07-aug-2020 regarding an unsolicited valid serious case received from the patient. This case involves adult female patient who reported fast heart beat such that she though she was having a heart attack, had headache, dizziness, felt tired, numbness and tingling in arm (paresthesia and hypoesthesia) and received injection in shoulder (off label use), with use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient was sensitive to many drugs. On an unknown date in (b)(6) 2020, the patient received hylan g-f 20, sodium hyaluronate (formulation: solution for injection) at a dose of 6 ml once via unknown route (lot - unknown) for unknown indication in her shoulder (off label use). Information regarding batch number was requested. On an unknown date in 2020 after a latency of few days had a headache, dizziness, felt tired, numbness and tingling in her arm and a fast heartbeat such that she thought she was having a heart attack (seriousness criteria: medically significant). Action taken: not applicable for all events. It was not reported if the patient received a corrective treatment. The patient outcome is reported as not applicable for received injection in shoulder (off label use); recovered for rest of the events. A product technical event was initiated and the results for the same were pending.
 
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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
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key10384094
MDR Text Key209595368
Report Number2246315-2020-00090
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 consumer
Type of Report Initial,Followup
Report Date 08/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? 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: 08/10/2020 Patient Sequence Number: 1
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