inforMED
InjuryFCE

BAG,ENEMA,W/SLIDE CLAMP,POLYBAG

Received Nov 22, 2024 · Event occurred Feb 13, 2023

Report 1417592-2024-00983 · MDR key 20762820

Device

Generic name

Bag,enema,w/slide Clamp,polybag

Catalog number

DYND70102

Product problems

  • Appropriate Device Problem Term/Code Not Available
  • Appropriate Device Problem Term/Code Not Available

Patient

NA · Unknown

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

ACCORDING TO THE FACILITY ON (B)(6)2023 THE "BLUE ENEMA CAP WAS NOTED IN RECTAL LUMEN DURING PERI CARE FOLLOWING VANCOMYCIN ENEMA ADMINISTRATION".

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY ON (B)(6)2023 THE "BLUE ENEMA CAP WAS NOTED IN RECTAL LUMEN DURING PERI CARE FOLLOWING VANCOMYCIN ENEMA ADMINISTRATION". PER THE FACILITY THE CAP WAS REMOVED DIGITALLY WITHOUT INVASIVE INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.