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Lot Number 7RSL021
Device Problem Device Contamination With Biological Material (2908)
Patient Problems Erythema (1840); Inflammation (1932); Pain (1994); Swelling (2091)
Event Date 01/01/2017
Event Type  malfunction  
Event Description
This case is cross referred with the case (b)(4) (cluster). This unsolicited case from united states was received on 15-dec-2017 and 02-jan-2018 (both information processed together with clock start date of 15-dec- 2017) from other non-health care professional. This case concerns a (b)(6) years old female patient who received treatment with synvisc one injection and after unknown latency patient had inflammation. Also device malfunction was identified for the reported lot number. No medical history, past drug, concomitant medication and concurrent condition was provided. Patient had no prosthetic devices, and was not treated with immunosuppressants. Overall health of the patient was good and had no history of allergies to avian products. On (b)(6) 2017, patient received treatment with intraarticular synvisc one injection (batch/lot number: 7rsl021 and dose, indication, frequency, expiration date: not provided). The syringe was stored properly and opened in the office with the patient. The area was cleaned topically with a disinfectant, but no other injectables were used at time of synvisc-one. The area was sprayed with an anesthetic topically before injection. On an unknown date in 2017, latency unknown, patient had pain and swelling. Swelling was reported to be doubled the knee size, red, hot, but no fever. It was reported that patient presented within 2 days of receiving the injection. Patient had the knee aspirated one week following the injection and the aspirate lab results were not known. The patient recovered with treatment of aspiration and meloxicam (mobic) for pain and inflammation. It was reported that patient was not hospitalized. Corrective treatment: aspiration, meloxicam (mobic) for inflammation; not reported for device malfunction. Outcome: recovered for both 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 is under investigation. Once this investigation is completed, corrective and preventive actions will be implemented. Seriousness criteria: important medical event for device malfunction pharmacovigilance comment: sanofi company comment dated 10-jan-2018: this case concerns a patient who has received synvisc one injection from the recalled lot and later experienced inflammation. 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 Key7187797
MDR Text Key97876536
Report Number2246315-2018-00127
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 Answer Provided
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