WIDEBAND¿ SELF-ADHERING MALE EXTERNAL CATHETER

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: SECTIONS 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 THERE WAS A NECROTIC ISSUE ON MULTIPLE PATIENTS, APPEARS TO CLINICIANS THAT IT WAS A PRESSURE INJURY RELATED TO MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS A NECROTIC ISSUE ON MULTIPLE PATIENTS, APPEARS TO CLINICIANS THAT IT WAS A PRESSURE INJURY RELATED TO MALE EXTERNAL CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

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. INSTRUCTIONS FOR USE WERE REVIEWED FOR THIS INVESTIGATION. THE LABELING IS FOUND TO BE ADEQUATE. A DHR COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTIONS 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.