Reference record (b)(4).The device manufacturer and lot number of the peg tube involved in this event was not provided by the complainant.Therefore, it is unknown if the tubing involved was the abbvie peg tube.Abbvie has chosen to report this event due to the potential that the peg tube involved could have been the abbvie peg tube.The device involved in the event was not returned, it remains implanted; 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) 2021, patient in (b)(6) was started on duopa therapy using percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.The report indicated that within one week, the patient developed stoma site infection.The stoma site was swabbed and patient was started on antibiotic flucloxacillin 1gm four times a day with effect.
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