MAUDE Adverse Event Report

According to the information the patient went to er due to excessive vaginal and bladder bleeding. Physician's checkups with patient at 2 & 6 weeks showed no problems with the obtape sling procedure. Patient did well with the obtape sling. Patient expired at the hospital. Information from physician indicated that the obtape sling did not contribute to the patient's condition. The information received also noted that no autopsy was performed.

As included in the discharge summary, the final diagnoses at the time of discharge/death included: 1) shock, 2) metabolic acidosis, 3) coagulopathy, 4) diabetes, 5) hpothyroidism, and 6) prosthetic aortic valve. Based on previously obtained information from the urologist regarding bladder suspension surgery performed in 2004, uneventful routine postoperative urology follow-up and the hospital records from her admission in 2005, mentor concludes the cause of death was most likely attributable to pre-existing co-morbidities as listed in numbers 1-6 of the final diagnoses.

Mentor received notification from another manufacturer in 2005 that patient was admitted emergently in about 2 weeks prior in hypovolemic shock and subsequently expired within 24 hours. The patient had previously undergone an ob-tape suburethral sling procedure in 2004. The treating urologist reported that pt was seen and examined post-operatively at two and six weeks. No complications, including bleeding, hematoma, vaginal discharge, edema or ecchymosis were evident on these exams or reported by the patient. Past medical history is significant for aortic valve replacement with associated anticoagulation therapy which was stopped temporarily for incontinence procedure and overall "not in good health" as described by their primary care provider. Based on the information obtained, there was no autopsy performed. The urologist feels the cause of death was from the co-morbidities of cardio-vascular disease and obesity and not related to the obtape sling procedure.