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 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.
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On (b)(6) 2021, patient in (b)(6) underwent procedure for the placement of percutaneous endoscopic gastrostomy with jejunal (peg-j) tube.The report indicated that the patient experienced stoma site discharge and inflammation.It was reported that the patient was hospitalized in the infectious disease department following an osteitis contracted a few months ago.The report indicated that the patient may have contracted a staphylococcus aureus , the peg tube was removed and the patient was treated with intravenous antibiotics.
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