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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 12/12/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 15-dec-2017 from a non-healthcare professional. This case concerns a (b)(6) male patient who received treatment with synvisc one and experienced redness, significant pain, swelling, warmth to both knees with the right knee being the worst knee (latency: 0 day); was having issues with walking/cannot walk (latency: unknown); also, device malfunction was identified for the reported lot number. The patient had osteoarthritis (oa) in bilateral knees. The patient had been getting the synvisc products since 2008. The patient reported no other preexisting health issues. On (b)(6) 2016, the patient received a synvisc one injection with batch/lot number: 6rsl037a; expiration date: aug-2019. The patient also received an injection on (b)(6) 2016. The concomitant medication was xylocaine for numbing the knee preinjection. No other medical history or concurrent condition was reported. On (b)(6) 2017, the patient received treatment with intra-articular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021) into bilateral knees for oa bilateral knees. It was reported that the doctor did use xylocaine for numbing the knee pre-injection but the reporter was not sure what prep was used to perform the sterile injections. The same day, after about one hour post injection, the patient experienced significant pain, swelling, redness and warmth to both knees with the right knee being the worst knee. On an unknown date in (b)(6) 2017, after unknown latency, the patient was having issues with walking. The patient went to the emergency department (ed) on (b)(6) 2017 for treatment as patient was having pain in both knees, could not walk or bend either knee. In the ed, they performed bloodwork, x-rays and ultrasound and also sent fluid for cultures. It was not known how much fluid was taken from the knees. It was reported that the cultures were pending and the patient was being seen today ((b)(6) 2017) and taking pain medications for the pain in the knees. The patient was not prescribed antibiotics until the test results came back. As of (b)(6) 2017, the patient was still in pain and was seen by the doctor that day and this was not resolved. Corrective treatment: unspecified medication for significant pain; not reported for rest of the events. Outcome: not recovered for significant pain; unknown for rest of 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 would be completed, corrective and preventive actions would be implemented. Seriousness criterion: important medical event (ime) for device malfunction pharmacovigilance comment: sanofi company comment dated 23-dec-2017: this case concerns a patient who suffered from localized erythema, knee swelling, knee pain, joint warmth and walking problems after receiving synvisc one injection from the recalled lot. Temporal relationship can be established between the events 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, the pharmacological plausibility of the events 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 Key7185261
MDR Text Key98009833
Report Number2246315-2017-00516
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
Remedial Action Recall
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
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 Received12/15/2017
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: 01/12/2018 Patient Sequence Number: 1