SPEEDICATH STANDARD URINARY INTERMITTENT DRAINAGE CATHETER

Description of Event or Problem

ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO REPORTS HOSPITALIZATION EARLIER THIS MONTH FOR 1 WEEK IN ICU AFTER AN INFECTION WHILE USING 28414 LOT (10)10507484 FROM 180MEDICAL. HE IS STILL ON ANTIBIOTICS. HE REPORTS HE HAS BEEN CATHING FOR 7+YEARS - REVIEWED CLEANING AND TECHNIQUE. EU REPORTS TOUCHING CATHETER ON LUBRICATED SURFACE AND HAS BEEN ADVISED AGAINST DOING THAT AND EDUCATED ON 27014 WITH PROTECTIVE GRIPPER. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Additional Manufacturer Narrative

WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.