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Lot Number 7RSL021
Device Problems Nonstandard Device (1420); Device Contamination With Biological Material (2908)
Patient Problems Pain (1994); Swelling (2091); Reaction, Injection Site (2442); Ambulation Difficulties (2544)
Event Date 12/01/2017
Event Type  malfunction  
Event Description
This unsolicited case from united states was received on 07-feb-2018 from a patient. This case concerns a (b)(6) male patient who received treatment with synvisc one and later on the same day couldn't stand for long, when he would get up and move,it felt like cramping, his knee was swollen like a grapefruit, was red and it was painful/pain was about 7-8 on a scale of 0-10( 10 the worst)/3 weeks later it topped and went back to his normal arthritis pain. Also device malfunction was identified for the reported lot number. No concomitant medication or concurrent condition was provided. The patient was not on immunosuppressants, no prosthetics except a mesh for a hernia. The patient never had a hylan product before. The patient had past treatment with cortisone injection. The patient had overall good health and was not allergic to bird products (only penicillin). On an unknown date in (b)(6) 2017 at around 10:00 a. M. To noon, the patient initiated treatment with intraarticular synvisc one injection at a dose of 6 ml once (batch/lot number: 7rsl021; indication and expiry date: unknown). The physician provided the syringe in the office, opened it there, cleaned the area with a disinfectant and gave the injection in his left knee. He did not inject anything else into the knee. He went home and took a nap. At 5 pm when the patient woke up his knee was swollen like a grapefruit and was red and painful. The same day, patient couldn't stand for long, but manned up until the following monday. It was reported that when he would get up and move, it felt like it was cramping. The same day, his pain was about 7-8 on a scale of 0-10 (10 the worst). About 2 days later, the pain started getting better. Reportedly, about 3 weeks later it topped and went back to his normal arthritis pain. He went to a different physician than the one who had given the injection on that monday. He did blood work and gave him an antibiotic (unspecified). It was reported that the first dose was a shot in his buttocks. He did not drain anything from his knee. He did not have a fever. Corrective treatment: not reported for device malfunction; antibiotics (unspecified) for rest of 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 would be completed, corrective and preventive actions would be implemented. Seriousness criteria: important medical event for device malfunction. Pharmacovigilance comment: sanofi company comment dated 12-feb-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced weight bearing difficulty, cramp, knee swelling, localized erythema and knee pain. 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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Manufacturer (Section D)
1125 pleadantview terrace
ridgefield NJ 07657
Manufacturer Contact
heather schiappacasse
55 corporate drive
bridgewater, NJ 08807
MDR Report Key7285106
MDR Text Key100922649
Report Number2246315-2018-00323
Device Sequence Number0
Product Code MOZ
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 02/07/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received02/21/2018
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? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/04/2018
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: 02/21/2018 Patient Sequence Number: 1