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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 Abdominal Pain (1685); Unspecified Infection (1930); Arthralgia (2355); Encephalitis (2429); Injection Site Reaction (4562); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/10/2021
Event Type  Injury  
Event Description
5 days of application began to have reactions such as pain in the knee, swelling and infection [injection site joint infection] ([pain in knee], [knee swelling]) pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found [joint effusion] case narrative: initial information received on 25-jun-2021 regarding an unsolicited valid serious case received from a consumer/non-hcp from (b)(6). This case involves a (b)(6) male patient who experienced after 5 days of application began to have reactions such as pain in the knee, swelling and infection and pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found while being treated with the use of medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history included surgery in (b)(6) 2020. His past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, he had concurrent condition of cholesterol. Concomitant medications included chondroitin sulfate, collagen, glucosamine (colagen) for arthrosis. On (b)(6) 2021, the patient started using hylan g-f 20, sodium hyaluronate, (formulation, dosage, lot number, route: unknown) for arthrosis. On the (b)(6) 2021, after the latency of five days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that after 5 days of application began to have reactions such as pain in the knee (arthralgia), swelling (joint swelling) and infection (injection site joint infection) (medically significant) that did not pass even after the use of several antibiotics. On (b)(6) 2021, after the latency if 20 days of starting the treatment with hylan g-f 20, sodium hyaluronate, patient experienced that patient had pulsion where a liquid was removed from his knee (joint effusion), but after the proper analysis, no change was found but still the infection rates were very high and was associated the application of the product. Action taken: unknown for all the events. Corrective treatment: antibiotics for 5 days of application began to have reactions such as pain in the knee, swelling and infection; fluid extraction for pulsion, where a liquid was removed from his knee, but after proper analysis, no change was found. Outcome: unknown for pulsion where a liquid was removed from his knee; not recovered for rest all the events. A product technical compliant was initiated with global ptc number:(b)(4) and results were pending for same.
 
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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 Key12106155
MDR Text Key266404621
Report Number2246315-2021-00122
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,foreign,health profe
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2021
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: 07/02/2021 Patient Sequence Number: 1
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