Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062910.The device involved in the event was not returned and was discarded; therefore, a return sample evaluation is unable to be performed.Stoma site infection is a known complication of a peg tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
|
On (b)(6) 2015, a patient in turkey underwent a procedure for the replacement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube, and began duopa/duodopa therapy on (b)(6) 2014.On (b)(6) 2019 the patient experienced a stoma site infection.On (b)(6) 2019 the peg/peg-j tube was removed and infection disease was consulted, results unknown.It was reported that the patient was treated with unspecified antibiotic medication for the stoma site infection.A nasojejunal tube (nj) has been placed and the patient will continue to receive duopa/duodopa therapy through the nj tube until stoma infection resolves.
|