If the perforated bowel is repaired through gastrointestinal resection and anastomosis, whereby the perforated, damaged section of the bowel is removed and the remaining sections reattached, it can lead to complications. Leakage at the repair site can lead to infection, and scaring at the repair site can lead to restricted interior flow.
Humanitarian use device. A Humanitarian use device (HUD), as defined by the Food and Drug Administration (FDA), is a device intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals per year in the United States.
âRESEARCH USE ONLYâ MEDICAL DEVICE: A medical device that has been made available to institutions/laboratories solely for their use in studies involving the collation of data. The device is not intended for any medical purpose or objective. DRAFT MEDICAL DEVICE GUIDANCE MAY 2014 ...