Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is 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.(b)(4).
|
This report pertains to the first of two hologic devices used in the same procedure.See associated medwatch, manufacturer's report # 1222780-2019-00109.It was reported that on (b)(6) 2019 a myosure tissue removal and novasure endometrial ablation were performed.On (b)(6) 2019 the patient presented to the emergency room with malodorous discharge, fever, and chills with a temperature of 102°f and uterine tenderness on examination.Her abdominal exam was negative for peritoneal signs.Her wbc count was 18,000 and a ct-scan demonstrated a 4cm fluid collection within the uterine cavity and a possible tubo-ovarian abcess along with thickened bowel wall.There was no suspicion for bowel perforation.The patient was admitted to the hospital and started on broad-spectrum antibiotics and an ultrasound was obtained.
|