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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombosis (2100); Arthralgia (2355); Joint Swelling (2356)
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 28-feb-2018 from a non-healthcare professional. This case concerns an adult female patient who received treatment with synvisc one and later after unknown latency had major swelling in injected knee/ leg, major swelling in injected knee/ leg and blood clot in injected knee/leg. No past drug, concomitant medication or concurrent condition was provided. The medical history included clotting disorder. On an unknown date, (within last couple of months) the patient initiated treatment with intra-articular synvisc one injection (dose, frequency, indication, batch/lot number and expiry date: unknown) into one unspecified knee. On an unknown date, after unknown latency, the patient was tested positive for a blood clotting disorder. On an unknown date, after unknown latency the patient had blood clot with major swelling and excruciating pain in the injected knee/leg. It was reported that the nurse injected steroid to help and patient was doing well. It was reported that the patient had clotting disorder prior starting treatment with synvisc one and she did not suspect that this problem is product related. Corrective treatment: not reported for blood clot in injected knee/leg; steroids for rest of the events outcome: recovering for all the events a global pharmaceutical technical complaint was initiated with (b)(4). The product lot number was not provided; therefore, a batch record review is not possible. Based on the lack of information provided, no capa is required. It is the requirement to review all finished batch records for specification conformance 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 safety surveillance effort to detect safety signals. This review has not indicated any safety issue. Sanofi will continue to monitor adverse events to determine if a capa is required. Seriousness criteria: important medical event for blood clot in injected knee/leg; required intervention for rest of the events additional information was received on 05-mar-2018. Gptc number and ptc results were added. Pharmacovigilance comment: sanofi company comment follow up dated 05-mar-2018: the follow up information does not change the prior assessment of the case. This case concerns a female patient who received synvisc one injection and later experienced a blood clot with "major swelling and excruciating pain" in the injected knee/leg. Based upon the information available, the causal role of the product cannot be denied for the occurrence of events. However, there is no information regarding the site and technique of injection and whether aseptic conditions were maintained during the injection. Further information regarding patient's current clinical presentation, any past or concomitant medications and other risk factors would aid in the complete medical assessment of the case.
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Manufacturer (Section D)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
bridgewater, NJ 08807
MDR Report Key7348407
MDR Text Key102756902
Report Number2246315-2018-00401
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/08/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/19/2018 Patient Sequence Number: 1