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U.S. Department of Health and Human Services


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Lot Number 7RSL021
Device Problem Microbial Contamination of Device (2303)
Patient Problems Pain (1994); Swelling (2091); No Code Available (3191)
Event Date 12/08/2017
Event Type  Injury  
Event Description
Pain [pain], swelling [swelling], device malfunction [device malfunction]. 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 health authority (fda) via healthcare professional. This case involves a patient (demographics: not provided) who received treatment with synvisc one and the after unknown latency had pain and swelling. Also, device malfunction was identified for the reported lot number. No past drugs, medical history, concomitant medication or concurrent condition was reported. On an unknown date, the patient received treatment with intra-articular synvisc one injection (dose, indication and frequency: not provided) (route, batch/ lot number: 7rsl021and expiration date: unknown). On (b)(6) 2017, after unknown latency, the patient had continued pain and swelling after injection. Corrective treatment: not reported for all the events outcome: unknown for all the events 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 was completed, corrective and preventive actions would be implemented. Seriousness criteria: medically significant for all the events. Pharmacovigilance comment: sanofi company comment dated dated 27-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced pain and swelling. Although a significant temporal relationship cannot be established with the product administration, but causal role cannot be denied as the concerned lot number has been identified to have malfunction by the company.
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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 Key7331036
MDR Text Key205504133
Report Number2246315-2018-00373
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