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Lot Number 7RSL021
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problems Nausea (1970); Pain (1994); Discomfort (2330); Arthralgia (2355); Joint Swelling (2356); Joint Disorder (2373); No Code Available (3191)
Event Date 11/20/2017
Event Type  Injury  
Event Description
This unsolicited case from united states was received on 02-jan-2018 from a patient. This case concerns a (b)(6) female patient who received treatment with synvisc one and later on the same day, was unable to bend right knee, increased pain, increased swelling and after unknown latency had elevated pancreatic enzymes. Also device malfunction was identified for the reported lot number. The patient had past treatment with several injections of synvisc one. The patient had medical history of knee pain (pain on a scale of 1-10 before the injection) and concurrent conditions include slightly high blood pressure (patient takes a low dose antihypertensive medication). The patient did not have any prosthetic device. The patient had no previous/concomitant treatment with immunosuppressant's. The patient had no allergy to avian proteins, feathers, or egg products. On (b)(6) 2017, the patient initiated treatment with intra-articular synvisc one injection at a dose of 6 ml once for osteoarthritis (batch/lot number: 7rsl021 and expiry date: unknown) into both the knees. The package was opened in room with patient before injection was given. The solution was prepared for disinfection. No medications were injected into the knee joint at the same time as synvisc one. The patient was admitted to hospital related to her being injected for 1 day. It was reported that the patient did not engage in activities such as jogging or tennis soon after the injection. The same day, the patient was unable to bend right knee at the time of hospitalization. Blood work was done in the hospital (results unknown). The same day, the patient had increased pain and swelling. It was reported that the patient was able to bear weight prior to injection and afterwards. No additional support was needed. The patient had pain on a scale of 4-5 and on scale of 1-10 pain was a 10 after injection. The patient did not have fever. On an unknown date, after unknown latency, the patient had elevated pancreatic enzymes (results unknown) which returned to normal after one day. It was reported that it took one week for the patient to recover. It was reported that the patient still had pain after discharge from hospital but not as severe. It was reported that the pain had returned as of 2 weeks after the injection and it was rated as 4-5 sometimes 7 on a scale of 1-10. Corrective treatment: unspecified medication for increased pain; not reported for rest of the events outcome: unknown for elevated pancreatic enzymes; recovered for increased swelling and unable to bend right knee; recovering for device malfunction, increased pain 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: hospitalization/prolongation for unable to bend right knee, increased pain, increased swelling and device malfunction. Pharmacovigilance comment: sanofi company comment dated 09-jan-2017: this case concerns a female patient who received synvisc one injection from the recalled lot for osteoarthritis and was hospitalized as she was unable to her right knee and had increased pain and swelling. 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 NJ 07657
Manufacturer (Section G)
1125 pleasantview terrace
ridgefield NJ 07657
Manufacturer Contact
darlene kadel
55 corporate drive, ms 55b-220
bridgewater, NJ 08807
MDR Report Key7214690
MDR Text Key98293947
Report Number2246315-2018-00098
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,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2018
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 Received01/02/2018
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/24/2018 Patient Sequence Number: 1