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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Fall (1848); Nausea (1970); Pain (1994); Swelling (2091)
Event Date 11/01/2017
Event Type  Injury  
Event Description
This spontaneous case from united states was received on 19-jan-2018 from patient this case concerns a (b)(6) female patient who initiated treatment with synvisc one and after an unknown latency couldn't put pressure on her knee, did not engage in any physical activity, felt tightness behind her knee and in the front of the knee, couldn't walk on her knee/walking with a limp, a fall due to wet pavement, swelling in her knee, felt pain, low-grade nausea, also, device malfunction was identified for the reported lot number. No medical history, previous medications, concomitant medications and concurrent conditions were reported. On (b)(6) 2017, patient received treatment with intra articular synvisc one injection once (dose and indication: not provided; batch/ lot number: 7rsl021 and expiry date: unknown). On an unknown date in (b)(6) 2017, after an unknown latency, she experienced swelling in her knee. She stated she felt pain and couldn't walk on her knee for a couple of days or put pressure on her knee. She stated she felt tightness behind her knee and in the front of the knee. She stated that usually she had relief from the synvisc injections but this time she has no relief (device ineffective). She mentioned she was walking with a limp after the injection. She stated that she did not engage in any physical activity after the injection. She also mentions that she had to take bactrim at one point because she had a fall due to wet pavement and needed the bactrim for her elbow. She stated that the swelling and pain had gone down and the pain was like it was prior to the injection. She does state that she still had low-grade nausea that she has been experiencing since receiving the synvisc one. Corrective treatment: bactrim for a fall due to wet pavement; none for couldn't put pressure on her knee, did not engage in any physical activity, felt tightness behind her knee and in the front of the knee, couldn't walk on her knee/walking with a limp, swelling in her knee, felt pain, low-grade nausea outcome: recovering for swelling in her knee and felt pain; unknown for all other events seriousness criteria: important medical event for device malfunction an investigation was initiated as a result of an unexpected increase in the number of labelled adverse events received from the us market for synvisc one, lot 7rsl021. The product met all release testing at time of manufacture in june 2017. Retain samples were retested due to the unexpected increase in adverse events. Higher than expected endotoxin results were obtained. In addition, the presence of microbial contamination was also confirmed. The cause of these events is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Pharmacovigilance comment: sanofi company comment dated 27-jan-2018: this case concerns a patient who suffered from weight bearing difficulty, decreased activity, joint tightness, limping, fall, right knee swelling, right knee pain and nausea after receiving synvisc one injection from the recalled lot. Although exact event onset date has not been provided in the case, temporal relationship can still be established between the events (except for fall) and the suspect product based on the available information. Additionally, as the concerned lot number has been identified to have malfunction by the company. Therefore, pharmacological plausibility of the events (except fall) to the product cannot be excluded.
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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 Key7246738
MDR Text Key99208743
Report Number2246315-2018-00225
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 Patient
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/01/2020
Device Lot Number7RSL021
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 Received03/05/2018
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: 02/06/2018 Patient Sequence Number: 1