SPIRIT® HYDROCOLLOID ADHESIVE SHEATH
Received Aug 25, 2025 · Event occurred Aug 19, 2025
Report 1018233-2025-07005 · MDR key 22884290
Device
Generic name
Male External Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
35303
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Urinary Tract Infection
- Urinary Tract Infection
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT SAID PATIENT WAS NO LONGER USING THE MALE EXTERNAL CATHETER DUE TO URINARY TRACT INFECTIONS. DID NOT SPECIFICALLY SAY ITEM CAUSED URINARY TRACT INFECTIONS. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT SAID PATIENT WAS NO LONGER USING THE MALE EXTERNAL CATHETER DUE TO URINARY TRACT INFECTIONS. DID NOT SPECIFICALLY SAY ITEM CAUSED URINARY TRACT INFECTIONS. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Additional Manufacturer Narrative
THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE THIS INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS, AND NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE INSTRUCTIONS FOR USE AND LABELING WERE REVIEWED AND FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. ALL AVAILABLE UDI INFORMATION IS BEING PROVIDED PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.