Lot and serial number of the device not provided by the complainant; therefore, the udi, expiration and manufacturing dates are not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided by the complainant.The device involved in this event was not returned for evaluation purposes therefore visual and functional analysis of the product could not be performed.We are unable to confirm a relationship between the device and the issue reported and a definitive root cause for the reported event could not be determined.The information obtained during complaint investigation will be included in our global complaint trending and product surveillance will continue to monitor complaints of this type for adverse trends.If the product is received or additional information is obtained, the investigation will be reopened accordingly per standard operating procedure.
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It was reported that on (b)(6) 2023, after a myosure and a novasure procedure, the facility reported that the patient had hemoglobin level of 5.5.2 myosure devices were used, one reach and one xl to remove a fibroid.The patient was reported as having a very patulous cervix and was having her period at the time of the procedure.After the myomectomy the physician performed a novasure procedure successfully.All the procedures were reported successful, the patient was admitted to the pacu and was sent home the same day.No additional information received.
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