(b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the replacement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2019, the patient was visited by the gastroenterologist with reported pain and effusion of purulent fluid in the stoma area.The gastroenterologist informed the patient that it was an infection and prescribed ceclor 500mg (1x3) for 7 days.On (b)(6) 2019, the patient reported that her stoma was irritated, bleeding and effusing smelly liquid.Despite 5 days of treatment with the antibiotic recommended by the gastroenterologist, no effect was seen.The patient was advised to contact the physician again.
|