Reference record (b)(4).The device manufacturer and lot number of the device involved in this complaint was not provided.Therefore, it is unknown if the device involved was abbvie branded tubing.Conservatively, abbvie has chosen to report this complaint due to the potential that the device involved could have been abbvie branded tubing.The device involved in the event remained implanted 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 tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On (b)(6) 2020, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After teh tubing replacement on (b)(6) 2020, the patient experienced stoma site discharge, which had not improved with barrier ointment or diprogenta.In (b)(6) 2020, the patient underwent a culture which revealed sensitive to gentamycin.In (b)(6) 2020, the patient visited the outpatient clinic and was prescribed 500mg of oral ciprofloxacin.In (b)(6) 2021, the stoma site looked better and more calmer.
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