PREMIER SOFT CONVEX CERAPLUS UROSTOMY POUCH CUT-TO-FIT
Received Feb 2, 2021 · Event occurred Jan 8, 2021
Report 9616668-2021-00002 · MDR key 11265431
Device
Generic name
Premier Soft Convex Ceraplus Urostomy Pouch Cut-to-fit
Manufacturer
Hollister IncorporatedCatalog number
84134
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
76 YR
- Urinary Tract Infection
- Urinary Tract Infection
Narrative
Additional Manufacturer Narrative
A REVIEW OF THIS SKU OVER THE LAST 3 YEARS SHOW NO OTHER REPORTS OF SUCTION OR URINE BACKUP. DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE AFFECTED POUCHES WERE NOT RETURNED SO SAMPLE EVALUATION IS NOT POSSIBLE. END USER'S WEIGHT IS NOT KNOWN SO AN ESTIMATION WAS USED. THE ROOT CAUSE OF THE SUCTION NOT ALLOWING THE URINE TO FLOW INTO THE TUBING COULD NOT BE DETERMINED. HOLLISTER IS SENDING A SAMPLE OF A DIFFERENT TYPE OF POUCH TO SEE IF THIS WORKS BETTER FOR THE END USER. IT IS NOT KNOWN IF THE POUCH SUCTION CAUSED OR CONTRIBUTED TO THE REPORTED INFECTION.
Description of Event or Problem
AN END USER REPORTED THAT HIS HOLLISTER UROSTOMY POUCH DEVELOPED A SUCTION AFTER 2 - 3 DAYS OF USE AND DIDN'T ALLOW URINE TO FLOW DOWN INTO THE TUBING. HE THEN EXPERIENCED ABDOMINAL DISCOMFORT AND WAS DIAGNOSED WITH A URINARY TRACT INFECTION REQUIRING ANTIBIOTICS. THE END USER BELIEVES THAT THE SUCTION IN THE UROSTOMY POUCH CAUSED A BACKFLOW OF URINE INTO HIS KIDNEYS RESULTING IN THIS INFECTION.