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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR INJECTION

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GENZYME CORPORATION(RIDGEFIELD) SYNVISC ONE INTRA-ARTICULAR INJECTION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); Therapeutic Response, Decreased (2271)
Event Date 12/29/2017
Event Type  Injury  
Event Description
Knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein [clot blood]. If applying warm compresses could have made synvisc less effective [therapeutic response decreased]. Case narrative: this unsolicited case from united states was received on 11-may-2018 from consumer (patient). This case concerns a (b)(6) female patient who received treatment with synvisc one injection and her knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein (latency: 7 days) and wondered if applying warm compresses could have made synvisc less effective (therapeutic response decreased) patient had a right knee surgery last autumn to clean out torn cartilage in right knee. Patient also has a shoulder issue. No relevant past drugs and concomitant medications were reported. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection, via intra-articular route once, at the dose of 6 ml (indication, lot number and expiration date: not reported). On (b)(6) 2017, 7 days after receiving the injection, the patient's knee did not feel right and she was diagnosed with blood clot in that leg. Ultrasound revealed partially occlusive blood clot in calf vein. She was advised using compression stocking; took baby aspirin and applied warm compresses to back of knee for clot. Patient wondered if applying warm compresses could have made synvisc less effective, but was advised that its gel-like mixture stays in joint space. Patient reported that her knee was feeling weird before synvisc injection. She also reported having bilateral synvisc-one injections previously with better results and more relief. Corrective treatment: compression stocking and baby aspirin for knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein. Outcome: unknown for knee did not feel right/ blood clot in that leg/ partially occlusive blood clot in calf vein. A pharmaceutical technical complaint (ptc) was initiated on 04-jun-2018 for synvisc one batch number unknown 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 had not indicated any safety issue. Sanofi would continue to monitor adverse events to determine if a capa was required. Seriousness criterion: medically significant for knee did not feel right/blood clot in that leg/ partially occlusive blood clot in calf vein additional information was received on 04-jun-2018. Global ptc number and ptc results were added. Text was amended accordingly. Local comments: report scheduled with delay after case completion due to (b)(4) roll out report scheduling issue on archived cases.
 
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Brand NameSYNVISC ONE
Type of DeviceINTRA-ARTICULAR INJECTION
Manufacturer (Section D)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
GENZYME CORPORATION(RIDGEFIELD)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8394051
MDR Text Key137946763
Report Number2246315-2018-00870
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
Type of Report Initial
Report Date 03/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
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: 03/06/2019 Patient Sequence Number: 1
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