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 october 5th , a patient who had a history of retained products of conception received a myosure procedure in which a false passage created in a previous procedure 3 weeks prior was discovered , during the myosure procedure there was excess of blood and the fluid deficit augmented rapidly for which the procedure was aborted.The patient was transferred to the operating room for a diagnostic laparoscopy which revealed that the patient had a previous uterine perforation that due to the irrigation during this procedure reopened.The last know status of the patient is that it was stable.No other information is available.
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