Reference number (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 cannot 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.
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On (b)(6) 2022, a patient in spain underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On (b)(6) 2022, the patient experienced stoma site pain and redness.On (b)(6) 2022, the patient experienced stoma site cellulitis.On (b)(6) 2022, the patient was seen on a routine basis by her neurologist and was prescribed dalacin 300 mgr every six hours for seven days.
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