inforMED
MalfunctionFCE

UNSPECIFIED ENEMA SYRINGE

Received Feb 19, 2002 · Event occurred Jan 1, 2002

Report 1520456-2002-00001 · MDR key 377428

Device

Generic name

Enema Syringe

Model number

NA

Catalog number

UNK

Lot number

UNK

Product problems

  • Use of Device Problem
  • Split

Patient

*

  • Bleeding

Narrative

Description of Event or Problem

RECEIVED REPORT OF A SPLIT ENEMA PIPE. IT WAS REPORTED THAT A CONSUMER WAS USING AN ENEMA PIPE IN THE CONSUMER'S NOSTRIL FOR FLUSHING PURPOSES. THE PIPE SPLIT AND AN UNSPECIFIED AMOUNT OF BLEEDING OCCURRED. THE CONSUMER REALIZES THE THEY WERE NOT USING THE PRODUCT AS IT WAS INTENDED. HOWEVER, THE CONSUMER SAID THE PROCEDURE WORKS BEST FOR THEM AND THE CONSUMER WILL CONTINUE TO USE THE ENEMA PIPE IN THIS MANNER.