ABBVIE - MEDICAL DEVICE CENTER DUODOPA_DUOPA; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Catalog Number 062943 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 11/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Reference record (b)(4).Catalog number is the international list number which is similar to us list number of 062918.It was unknown if the device involved in the event was discarded or will be returned; therefore, a return sample evaluation is unable to be performed.However, if the device is received, a follow up report will be submitted upon completion of the return sample investigation.(b)(4).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 an unknown date, a patient in (b)(6) underwent a procedure for the placement of percutaneous endoscopic gastrostomy (peg) tube with jejunal (peg-j) tube.On unknown dates in (b)(6) 2019, the j-tube retracted by about half the length.The physician attempted to replace the j-tube, but it was coiled and caught on food and debris in the stomach.The j-tube was removed, and the patient underwent an unspecified abdominal surgery.A new j-tube will be placed when the patient has healed from the abdominal surgery.
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