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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Arthralgia (2355); Joint Swelling (2356); Sleep Dysfunction (2517); No Code Available (3191)
Event Date 12/08/2017
Event Type  Injury  
Event Description
Effected sleep [sleep disturbance]. Effected mobility [movement disorder]. Device malfunction [device malfunction. ] right knee remained painful [knee pain]. Swelling knee [knee swelling]. Right knee is tight [stiff knees]. Case narrative: case was initially submitted via sanofi legacy database and is now being re-distributed to fda at their request. This unsolicited case from united states was received on 27-feb-2018 from a healthcare professional via health authority (usa-fda: food and drug administration, reference number: mw5074671). This case involves a patient (demographics not provided) who received treatment with synvisc one and after unknown latency experienced right knee remained painful, effected sleep, effected mobility, swelling knee and right knee is tight. Also, device malfunction was identified for the reported lot number. No relevant medical history, past drugs, concomitant medications and concurrent conditions were reported. On an unknown date in 2017, the patient received treatment with intra-articular synvisc one, injection (batch/lot number: 7rsl021; dose, frequency, indication: not provided). Since (b)(6) 2017, after unknown latency, the patient experienced swelling rt. Knee was tight remained painful and effected sleep and mobility. Corrective treatment: not reported. Outcome: unknown for all the events. Seriousness criteria: medically significant for all the events. A product technical complaint was initiated with the following results: 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 was under investigation. Once this investigation is completed, corrective and preventive actions would be implemented. Pharmacovigilance comment: sanofi company comment dated 07-mar-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced swelling knee, right knee is tight, remained painful and effected sleep and mobility. A temporal relationship can be established with the product administration. Furthermore, the concerned lot number has been identified to have malfunction by the company. Therefore, the causal relationship of the events to the products cannot be excluded.
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Type of DeviceMOZ
Manufacturer (Section D)
1125 pleasantview terrace
ridgefield 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
bridgewater 08807
MDR Report Key7331048
MDR Text Key213224323
Report Number2246315-2018-00374
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 health professional
Remedial Action Recall
Type of Report Initial
Report Date 08/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number7RSL021
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: 03/12/2018 Patient Sequence Number: 1