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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 Arthritis (1723); Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907)
Event Date 10/01/2015
Event Type  Injury  
Event Description
Cellulitis [cellulitis]. Septic arthritis [septic arthritis]. Allergic reaction to synvisc [allergic reaction]. Case narrative: initial information was received on 08-dec-2020 regarding a solicited valid serious case from a physician, in the scope of market research program (b)(4). (b)(6). This case involves a (b)(6) years old female patient who experienced cellulitis, septic arthritis and allergic reaction to synvisc, after with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided. On an unknown date, the patient started using synvisc (hylan g-f 20, sodium hyaluronate) (with an unknown batch number, dose, frequency, route and indication). Information on batch number was requested. On an unknown date in (b)(6) 2015, after unknown latency, the patient experienced moderate septic arthritis (arthritis bacterial), moderate cellulitis and moderate allergic reaction to synvisc (hypersensitivity). The patient was hospitalized for all the reported events. The events of cellulitis and septic arthritis were assessed as medically significant. The patient received unspecified antibiotics as corrective treatment for the events. Final diagnosis was allergic reaction to synvisc, septic arthritis and cellulitis. Action taken: unknown for all the events. Corrective treatment: unspecified antibiotics for all the events. The patient outcome is reported as unknown for all the events. Reporter causality: unassessable for all the events. Company causality: reportable for all the events. A product technical complaint (ptc) was initiated, and results were pending for the same.
 
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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 Key11018524
MDR Text Key226771419
Report Number2246315-2020-00169
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Type of Report Initial
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/16/2020 Patient Sequence Number: 1
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