(b)(6) performed an analysis of public database and found a maude adverse event report involving a (b)(6) product from 2019.(b)(6) was not aware of this event until (b)(6) 2021.Mdr report key: mw5096005 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.According to the ifu for myosure tissue removal device in the first page in contraindications: the myosure tissue removal system should not be used with pregnant patients or patients exhibiting pelvic infection, cervical malignancies, or previously diagnosed uterine cancer.
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