MALE EXTERNAL CATHETER
Received Sep 3, 2025 · Event occurred Aug 26, 2025
Report 1018233-2025-07430 · MDR key 22954755
Device
Generic name
Male External Catheter
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
UNK
Lot number
UNK
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Unspecified Infection
- Unspecified Infection
Narrative
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 PRODUCT CATALOG NUMBER FOR THIS DEVICE IS UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 THE PATIENT WAS HOSPITALIZED HAD AN INFECTION ON HIS INNER THIGH. DOCTOR STATED POSSIBLE DUE TO THE MALE EXTERNAL CATHETERS. UNSURE WHICH ONE SINCE THE PATIENT WAS SENT MANY SAMPLES TO TRY. ADVISED THAT IT IS REALLY IMPORTANT THAT WHEN HE REMOVES THE MALE EXTERNAL CATHETER TO MAKE SURE ALL OF THE PENIAL REGION, PUBIC REGION, AND THIGHS BE THOROUGHLY CLEANED TO AVOID BACTERIAL RESIDUE BUILDING UP. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. 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 THE PATIENT WAS HOSPITALIZED HAD AN INFECTION ON HIS INNER THIGH. DOCTOR STATED POSSIBLE DUE TO THE MALE EXTERNAL CATHETERS. UNSURE WHICH ONE SINCE THE PATIENT WAS SENT MANY SAMPLES TO TRY. ADVISED THAT IT IS REALLY IMPORTANT THAT WHEN HE REMOVES THE MALE EXTERNAL CATHETER TO MAKE SURE ALL OF THE PENIAL REGION, PUBIC REGION, AND THIGHS BE THOROUGHLY CLEANED TO AVOID BACTERIAL RESIDUE BUILDING UP. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.