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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 Erythema (1840); Pain (1994); Ambulation Difficulties (2544); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Unable to walk for two to three months [unable to walk], left knee became swollen, red, painful [injection site joint swelling], left knee became swollen, red, painful [injection site joint pain] ([device ineffective]), left knee became swollen, red, painful [injection site joint redness], caused water on his knee (left) [injection site joint effusion]. Case narrative: this case is submitted following an incorrect worldwide id in case id ((b)(4)) which will be deleted. This report contains no new information. Initial information received on 18-jan-2021 regarding a solicited valid serious case received from patient, in the scope of post-marketing sponsored study "spon_i_synvisc one". Patient id: unknown; country: (b)(6). Study title: patient support program involving synvisc one. The case is linked to case (b)(4) (multiple devices for right knee). This case involves adult male patient who experienced unable to walk for two to three months, left knee became swollen, red, painful and caused water on his knee (left), while he using with the use of medical device 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 an unknown date, the patient started using hylan g-f 20, sodium hyaluronate injection at the dose of 6 ml once via unknown route in left knee (lot - unknown) for osteoarthritis. Information on the batch number was requested. It was reported that injection that it did not work for him and there was lack of efficacy (device ineffective; onset, latency: unknown). On an unknown date, once receiving the injections (after unknown latency), patient's knee became swollen (injection site joint swelling), red (injection site joint erythema), painful (injection site joint pain) and he was unable to walk for two to three months (gait inability; event assessed as serious due to disability) and it caused water on his knee (injection site joint effusion). Action taken: not applicable for all events. It was not reported if the patient received a corrective treatment. Outcome: unknown for injection site joint erythema and injection site joint effusion, recovered for rest of the events. Reporter causality: not reported for injection site joint erythema and injection site joint effusion, related for rest of the events. Company causality: not reportable for all events. A product technical complaint (ptc) was initiated on 19-jan-2021 for synvisc one for unknown batch number and global ptc number: (b)(4). The product lot number was not provided; therefore, a batch record review was not possible. 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 (non-conformances report) process. Adverse event reports with or without lot numbers were continuously monitored, and possible associations with their corresponding product lot are assessed, as part of routine safety surveillance effort to detect safety signals. This review has not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa (corrective and preventive action) was required. Investigation completion date: 22-jan-2021. The global ptc number: (b)(4) has been reopened due to incomplete information. Additional information was received on 19-jan-2021 (non-significant), 22-jan-2021 (significant), 27-jan-2021 (significant) (processed with clock start date of 22-jan-2021) from healthcare professional. Global ptc number and its results were added. Text amended accordingly. Follow up was received on 01-feb-2021 from healthcare professional. Global ptc number (b)(4) was cancelled. Text amended accordingly. Follow up was received on 01-feb-2021 from healthcare professional. Global ptc number (b)(4) was cancelled. Text amended accordingly. Follow up information was received on 20-feb-2021. Information regarding global ptc number: (b)(4) added.
 
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Brand NameSYNVISC ONE
Type of DeviceMOZ
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 Key11974145
MDR Text Key268214440
Report Number2246315-2018-00887
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,s
Type of Report Initial
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
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 Answer Provided
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: 06/10/2021 Patient Sequence Number: 1
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