A1-a6) only patient information available was the patient's age.D4) model number is xeridiem's part number; catalog number is exclusive distributor (boston scientific) part number which appears on the label.G3) mdr filed based on retrospective complaint review done in october 2023; this report is for xeidiem complaint number (b)(4).H3) device has not been evaluated because it has not been returned.Therefore, the allegation of bolster movement causing stoma infection cannot be confirmed.Nothing in reviewed production records for lot indicated any potential issue that could cause the alleged problem.H6) codes chosen based on reported information; since device was not returned and investigation did not find evidence of a bolster issue, the alleged problem could not be confirmed.
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