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MALECOT RUSSEL GASTROSTOMY CATHETER
Received Oct 22, 2003 · Event occurred Sep 5, 2003
Report 1820334-2003-00185 · MDR key 492249
Device
Generic name
Catheter
Manufacturer
Cook, Inc.Model number
NACatalog number
ULT10.2-NT-25-P-NS-RMGS
Lot number
UNK
Product problems
- Dislodged
- Replace
Patient
53 YR
- Surgical procedure, repeated
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
THE PATIENT DEVELOPED CEREBRAL HEMORRHAGE IN 2003, AND UNDERWENT THE PEG DUE TO DYSPHAGY AS SEQUELA OF THE CEREBRAL HEMORRHAGE AT A HOSPITAL, WHERE THE DEVICE WAS FIRST PLACED 4 MONTHS EARLIER. APPROXIMATELY 100 DAYS AFTER PLACEMENT, THE CATHETER CAME OUT SPONTANEOUSLY DUE TO THE CLOSURE OF THE MALECOT. THE PHYSICIAN ADVISES THE CATHETER WAS FLUSHED AFTER EACH DRUG ADMINISTRATION. MINOR SWELLING WAS OBSERVED ON THE CATHETER SHAFT, APPROXIMATELY 7CM FROM THE TIP. THE PATIENT UNDERWENT THE SECOND PEG.