UNKNOWN MALE EXTERNAL CATHETER

Description of Event or Problem

IT WAS REPORTED THAT THE CRITICAL CARE NURSE STATED THAT THE ONLINE SURVEY A NURSE STATED THAT THE "ULTRAFLEX SELF-ADHERING MALE EXTERNAL CONDOM CATHETER" WAS THE PRODUCT USED. ADDITIONALLY, THE NURSE STATED "YES" FOR THE QUESTIONS: "DID YOUR PATIENT EXPERIENCE PENILE SKIN IRRITATION AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE SKIN ULCERATION AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE BLEEDING AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE EDEMA AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE URETHRAL INJURY AS A RESULT OF DEVICE USAGE?" AND "DID YOUR PATIENT EXPERIENCE A UTI AS A RESULT OF DEVICE USAGE?". BESIDES, IN QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT EXPERIENCE ANY OTHER ADVERSE EVENTS?" THE NURSE STATED "YES" AND FOR THE QUESTION "PLEASE DESCRIBE THE OTHER ADVERSE EVENT(S) EXPERIENCED BY YOUR LAST PATIENT WHEN CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED THE BARD/BD MALE EXTERNAL CONDOM CATHETER." THE ANSWER WAS "N/A". FURTHERMORE FOR THE QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF DEVICE USAGE?" THE NURSE STATED "YES" AND IN QUESTION "PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED WHEN CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED THE BARD/BD MALE EXTERNAL CONDOM CATHETER." ANSWERED "N/A".

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. A LABELING REVIEW COULD NOT BE PERFORMED SINCE NO MATERIAL NUMBER WAS PROVIDED. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. NO ADDITIONAL ACTIONS CAN BE TAKEN AT THIS TIME. 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 THE CRITICAL CARE NURSE STATED THAT THE ONLINE SURVEY A NURSE STATED THAT THE "ULTRAFLEX SELF-ADHERING MALE EXTERNAL CONDOM CATHETER" WAS THE PRODUCT USED. ADDITIONALLY, THE NURSE STATED "YES" FOR THE QUESTIONS: "DID YOUR PATIENT EXPERIENCE PENILE SKIN IRRITATION AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE SKIN ULCERATION AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE BLEEDING AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE EDEMA AS A RESULT OF DEVICE USAGE?", "DID YOUR PATIENT EXPERIENCE PENILE URETHRAL INJURY AS A RESULT OF DEVICE USAGE?" AND "DID YOUR PATIENT EXPERIENCE A UTI AS A RESULT OF DEVICE USAGE?". BESIDES, IN QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT EXPERIENCE ANY OTHER ADVERSE EVENTS?" THE NURSE STATED "YES" AND FOR THE QUESTION "PLEASE DESCRIBE THE OTHER ADVERSE EVENT(S) EXPERIENCED BY YOUR LAST PATIENT WHEN CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED THE BARD/BD MALE EXTERNAL CONDOM CATHETER." THE ANSWER WAS "N/A". FURTHERMORE FOR THE QUESTION "CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED A BARD/BD MALE EXTERNAL CONDOM CATHETER ON YOUR PATIENT, DID YOUR PATIENT REQUIRE ANY MEDICAL OR SURGICAL INTERVENTION AS A RESULT OF DEVICE USAGE?" THE NURSE STATED "YES" AND IN QUESTION "PLEASE DESCRIBE THE MEDICAL OR SURGICAL INTERVENTION THAT RESULTED WHEN CONSIDERING THE 24-HOUR PERIOD IN WHICH YOU LAST USED THE BARD/BD MALE EXTERNAL CONDOM CATHETER." ANSWERED "N/A".

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.