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Life Threatening? Yes
Write-up: Information has been received from a medical assistant concerning a 7 month old male with NKDA and no pertinent medical history, who was given 3 doses of ROTATEQ, 2 ml, and developed intussusception. The patient received his first dose on 16-APR-2008 (lot # 660291/1829U), the second dose on 16-JUN-2008 (lot # 660596/0211X) and the third dose on 31-JUL-2008 (lot # 660679/0407X). Concomitant therapy included PEDIARIX, ACTHIB, PREVNAR and DTaP (unspecified). The patient went to the hospital ER on 13-SEP-2008 and was then transported to another hospital and hospitalized with intussusception. The patient had a GI obstruction, surgical repair work on the intussusception, and his appendix was removed. The patient was in the neonatal intensive care unit. The medical assistant states she does not have the medical charts from the hospital, and does not know if the patient has been discharged from the hospital. However, the caller states she thinks the child is "recovering, getting better". Blood lab work and lots of unspecified tests were performed. No product quality complaint involved. Intussusception and appendix disorder were considered to be immediately life-threatening, disabling and other important medical events. A lot check has been requested. Additional information has been requested. 9/25/08-records received for DOS 9/13-9/21/08-DC DX: Colonic perforation. Presented to ED with current jelly bowel movements and emesis suggestive of intussusception. Open reduction intussusception with incidental appendectomy performed on 9/14/08-Subsequently developed severe abdominal pain associated with severe tachycardia. Intubation. Returned to OR for exploratory lap, repair of colonic perforation. NG tube insertion. Recovered and discharged home.
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