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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 9RSL036B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Erythema (1840); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 08/06/2020
Event Type  Injury  
Event Description
Pseudosepsis [pseudosepsis] ([joint warmth], [aching (r) knee], [localized erythema], [swelling of r knee], [effusion (r) knee], [synovial fluid culture positive], [staphylococcus test positive]). Case narrative: the case is linked to (b)(4) (cluster). Initial information received on 14-aug-2020 regarding an unsolicited valid serious case received from other healthcare professional via call center from united states. This case involves a (b)(6) years old male patient who experienced pseudosepsis, while he was treated with 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. On (b)(6) 2020, the patient received treatment with hylan g-f 20, sodium hyaluronate solution for injection in right knee (prior to which effusion was removed from right knee) at dose of 48 mg once via unknown route (batch number - 9rsl036b; expiration date: unknown) for oa (osteoarthritis). On (b)(6) 2020, three days after administration of hylan g-f 20, sodium hyaluronate, patient reported severe heat, pain, redness and swelling (right knee). On an unknown date in (b)(6) 2020, after latency of few days healthcare professional removed effusion and sent for culture and results were staph (staphylococcus) and gram positive cocci. Patient was hospitalized for the same (unknown date (b)(6) 2020). Then, arthroscopic irrigation and drainage were performed and patient was administered iv (intravenous) antibiotics(unspecified). It was unknown if patient remained in hospital. No more information provided. Action taken: not applicable. Corrective treatment: arthroscopic irrigation, drainage performed and administered iv antibiotics. Outcome: unknown. A product technical complaint was initiated and results were pending for the 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 Key10419531
MDR Text Key209402091
Report Number2246315-2020-00097
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,Followup,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot Number9RSL036B
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: 08/18/2020 Patient Sequence Number: 1
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