(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: during a laparoscopic pancreaticoduodenectomy, the interceed was placed just under the abdominal wall in front of the small intestine.About 1 week after the operation, infection occurred.Abscess occurred along the area where the interceed had been.Placed.Drainage to prevent infection was ongoing when the event occurred.Hospitalization period was extended but the patient was recovered and has been already discharged.The patient demographic info: age, gender, weight, bmi at the time of index procedure.No further information is available.Date and name of initial surgical procedure? the procedure is laparoscopic pancreaticoduodenectomy.The date is unknown.The diagnosis and indication for the initial surgical procedure? pancreaticoduodenectomy.Where was interceed used/applied, what part/tissue/organ? the interceed was placed just under the abdominal wall in front of the small intestine.Other relevant patient comorbidities? no further information is available.Other concurrently implanted devices? no further information is available.Date, time of onset of infection from the surgical procedure? about 1 week after the operation.Location, severity and appearance of infection? abscess occurred along the area where the interceed had been placed.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no further information is available.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no further information is available.Were cultures performed? results? no further information is available.What medical intervention was performed? results? no further information is available.Product lot number? the lot number is unknown.What is physician¿s opinion as to the etiology of or contributing factors to this event (infection) ? no further information is available.What is the patient's current status? hospitalization period was extended but the patient was recovered and has been already discharged.No further information will be provided.
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