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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 Edema (1820); Pain (1994); Urinary Tract Infection (2120); Arthralgia (2355); Malaise (2359); No Code Available (3191)
Event Date 08/22/2019
Event Type  Injury  
Event Description
Kidney problem with leukocyturia/kidney difficulty [kidney disorder] ([leukocyturia]). Pain [pain]. Urinary infection [urinary infection]. Peripheral edema [edema peripheral]. Generalized malaise [general malaise]. Something inflammatory that have been caused by excretion of some medication, maybe not synvisc [unevaluable event]. Case narrative: based on additional information received on 20-sep-2019, this case initially considered as non-serious was upgraded to serious: ( due to events peripheral edema, generalized malaise, kidney problem with leukocyturia/kidney difficulty, urinary infection, pain with seriousness criteria: hospitalization). Initial information received from (b)(6) on 06-sep-2019 regarding an unsolicited valid serious case received from a physician. This case involves a (b)(6) male patient (165 cm and 52 kg) who experienced peripheral edema, generalized malaise, kidney problem with leukocyturia/kidney difficulty (latency: same day), something inflammatory that have been caused by excretion of some medication, maybe not synvisc, urinary infection, pain (latency few days) while he was treated with hylan g-f 20, sodium hyaluronate (synvisc). The patient's past medical history, medical treatment (s), vaccination (s) and family history were not provided. Concomitant medications included codeine phosphate, paracetamol (paco) for pain. On fifteen days ago, (estimated date (b)(6) 2019), patient started treatment with hylan g-f 20, sodium hyaluronate, injection at a dose of 2 units, unknown frequency, intra-articular route (with an unknown batch number, because it was applied at other location) for left knee arthrosis. Information on batch number was requested. On estimated date, (b)(6) 2019 (fifteen days ago), on same day after second injection of the three prescribed applications, patient had peripheral edema, generalized malaise, kidney problem with leukocyturia and kidney difficulty. Patient went to the medical office with those symptoms and even with medication (unspecified), the reaction did not end. It was also reported that, it was the first use of medical device for the patient. Reporter did not request product analysis. It was reported that patient's symptoms persisted and was hospitalized. On an unknown date in 2019, after latency of few days, patient had pain, urinary infection, for which he had not received any specific medication, however received a basic treatment for these events. Due to these, events, it was decided not to treat the other symptoms presented by the patient. On an unknown date, patient got recovered from urinary infection as culture test was performed which was negative. Due to this, physician believed it was something inflammatory that could have been caused by the excretion of some medicine, may be it was not hylan g-f 20, sodium hyaluronate. The physician also informed that he talked with sanofi doctor who did not believe the symptoms were related to hylan g-f 20, sodium hyaluronate. All the symptoms persisted, including leukocyturia. Action taken: unknown for something inflammatory that have been caused by excretion of some medication, maybe not synvisc, urinary infection, pain; drug withdrawn for rest all events. Corrective treatment: not reported for something inflammatory that have been caused by excretion of some medication; unspecified medication for rest all events. Outcome: unknown for something inflammatory that have been caused by excretion of some medication; recovered for urinary infection; not recovered/not resolved for rest all the events. A product technical complaint was initiated on (b)(6) 2019 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. Final investigation complete date: (b)(6) 2019. Additional information received on 12-sep-2019. Investigation summary received and ptc results added. Text amended accordingly. Additional information received on 20-sep-2019 from physician. Event of synvisc injected intramuscularly/product use issue situation deleted. Events of something inflammatory that have been caused by excretion of some medication, maybe not synvisc, urinary infection, pain added. Based on additional information received, case updated to serious. Clinical course updated and 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 Key9156514
MDR Text Key167784245
Report Number2246315-2019-00249
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 foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
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
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: 10/04/2019 Patient Sequence Number: 1
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