(b)(4).Catalog number is the similar us list number, the international list number is unknown.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 was not returned; therefore, a return sample evaluation is unable to be performed.Peritonitis is a known complication of a peg tube/j-tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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On an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube and started duopa treatment on (b)(6) 2019.On (b)(6) 2019, it was reported that the patient was treated for a wound exudate and peritonitis at the peg insertion site with unspecified antibiotic medication.The treatment of stoma site caused restless nights and delirium, which was remedied with clozapine.
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