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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cramp(s) (2193); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Stiffness in right knee [stiff knees], swelling in right knee [swelling of r knee], pain in right knee [aching (r) knee], cyst at the level of the popliteal fossa (right knee) [popliteal cyst], heavy leg on the right [heaviness in leg], cramps in the calf on the right [cramps calf]. Case narrative: this case is linked to case (b)(4) (same patient). Initial information received on 31-oct-2019 regarding an unsolicited valid serious case received from a patient from france. This case involves a (b)(6) years old male patient who after unknown latency experienced stiffness in right knee, swelling in right knee, pain in right knee, cyst at the level of the popliteal fossa (right knee), heavy leg on the right and cramps in the calf on the right, while he used the medical device hylan g-f 20, sodium hyaluronate (synvisc one). The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided. Patient was treated with hylan g-f 20, sodium hyaluronate (synvisc one) for 10 years in the both knees every 7 to 8 months to allow him to continue his sport. The patient practiced many sport as the extensive cycle: 9 000 in 10 000 km a year and ski. On an unknown date in 2019, (around 7 or 8 months ago before (b)(6) 2019), the patient received hylan g-f 20, sodium hyaluronate injection via intra-articular route (infiltration), at a dose of 6 ml once (with an unknown batch number and expiration date) for osteoarthritis in right knee. On an unknown date in 2019, after unknown latency, the patient presented to the infiltration with a cyst at the level of the popliteal fossa which required a draining. On an unknown date in 2019, after unknown latency, during 2 weeks, the patient suffered of swelling, pain, stiffness in the right knee (assessed as serious due to disability marked). The patient used diclofenac sodium (voltarene) locally after the injection. The patient also experienced heavy leg and cramps in the calf on the right during 2 weeks. Patient had to walk with crutches during 2 days. During 2 weeks following the infiltration, patient could not have a practice any more of physical activity. Final diagnosis was cramps in the calf on the right, heavy leg on the right, cyst at the level of the popliteal fossa (right knee), pain in right knee, swelling in right knee and stiffness in right knee. Action taken: not applicable for all events. Corrective treatment: diclofenac sodium (voltarene) and crutches for pain in right knee, swelling in right knee and stiffness in right knee; draining (puncture) for cyst at the level of the popliteal fossa (right knee), not reported for other event outcome: unknown for all events. A product technical complaint was initiated for synvisc one (lot: unknown) on 05-nov-2019 with global ptc number (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. Based on the lack of information provided, no capa was required. It was the requirement to review all finished batch records for specification conformance prior to release. Any out of specification result was identified and mitigated through the ncr process. Sanofi global pharmacovigilance and epidemiology continuously monitored adverse event reports with or without lot numbers, and assessed possible associations with their corresponding product lot, as part of routine safety surveillance effort to detect safety signals. This review did not indicate any safety issue. Sanofi will continue to monitor adverse events to determine if a capa was required. Final investigation completion was 05-nov-2019. Additional information was received on 05-nov-2019 from other healthcare professional. Ptc results were received and text amended accordingly.
 
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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 Key9322461
MDR Text Key185106912
Report Number2246315-2019-00301
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 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
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: 11/14/2019 Patient Sequence Number: 1
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