WALGREENS PREMIUM COMBINATION DOUCHE AND ENEMA
Received Nov 8, 2017 · Event occurred Oct 1, 2017
Report 0002183416-2017-00001 · MDR key 7010255
Device
Generic name
Douche And Enema
Manufacturer
Apothecary Products, LlcModel number
02806WGLot number
322KB04
Product problems
- Detachment Of Device Component
- Misassembly by Users
- Detachment Of Device Component
- Misassembly by Users
Patient
Not reported
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE ENEMA PIPE WAS INCORRECTLY ATTACHED TO THE TUBING WITHOUT THE ADAPTER. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED.
Description of Event or Problem
USER STATED THAT WHILE USING THE ENEMA, THE TIP CAME LOOSE AND WENT INSIDE OF HER. USER WENT TO THE EMERGENCY ROOM WHERE THEY DID AN X-RAY AND GAVE HER MORPHINE BEFORE THEY WERE FINALLY ABLE TO RETRIEVE IT.
Additional Manufacturer Narrative
THE ENEMA PIPE WAS INCORRECTLY ATTACHED TO THE TUBING WITHOUT THE ADAPTER. THE ROOT CAUSE COULD NOT BE DEFINITIVELY DETERMINED.
Description of Event or Problem
USER STATED THAT WHILE USING THE ENEMA, THE TIP CAME LOOSE AND WENT INSIDE OF HER. USER WENT TO THE EMERGENCY ROOM WHERE THEY DID AN X-RAY AND GAVE HER MORPHINE BEFORE THEY WERE FINALLY ABLE TO RETRIEVE IT.