Catalog Number 062943 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ulcer (2274)
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Event Date 01/23/2022 |
Event Type
Injury
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Manufacturer Narrative
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Reference number (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Ulcer is a known complication of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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Event Description
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On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, during a routine peg/j tube replacement, an ulcer was observed in the antrum and a biopsy was taken.There were no biopsy results yet.The patient was treated with omeprazole 20 mg twice a day.
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Manufacturer Narrative
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Reference number (b)(4).Catalog number is the international list number which is similar to us list number of 062918.The device involved in the event remained in the patient and was not returned; therefore, a return sample evaluation is unable to be performed.Ulcer is a known complication of a peg- j tube placement.If any further relevant information is identified or obtained, a supplemental medwatch will be filed.
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Event Description
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On (b)(6) 2019, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.After an unspecified amount of time, during a routine peg/j tube replacement, an ulcer was observed in the antrum and a biopsy was taken.There were no biopsy results yet.The patient was treated with omeprazole 20 mg twice a day.
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Search Alerts/Recalls
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