GENTLECATH

Description of Event or Problem

END USER REPORTS SHE HAS PERFORMED "INTERMITTENT SELF-CATHETERIZATION FOR THE PAST 7 YEARS. SHE REPORTS HAVING UNDERGONE SURGERY ONE MONTH AGO BUT DID NOT SPECIFY THE TYPE OF PROCEDURE. SINCE THE RECENT HEATWAVE, SHE HAS EXPERIENCED ISSUES WITH HER GC AIR FEMALE CATHETERS, WHICH SHE DESCRIBES AS BEING "DRY" AND INSUFFICIENTLY LUBRICATED. ACCORDING TO THE PATIENT, THIS HAS LED TO A URINARY TRACT INFECTION, ACCOMPANIED BY DARK BROWN ("COFFEE-COLORED") URINE AND SIGNIFICANT PAIN DURING CATHETERIZATION. SHE ALSO REPORTS BEING UNABLE TO SIT COMFORTABLY DUE TO THE SEVERITY OF THE PAIN." SHE WAS OFFERED GC GLIDE CATHETERS AS AN ALTERNATIVE, HOWEVER, SHE DECLINED THIS OPTION BECAUSE SHE DOES NOT WANT THE INCONVENIENCE OF CARRYING A LUBRICANT SACHET WITH HER CATHETERS.END USER ALSO STATED "THE PACKAGING STATES THE CATHETERS SHOULD BE STORED AT TEMPERATURES BELOW 25°C. CONSEQUENTLY, SHE DOES NOT UNDERSTAND WHY THEY ARE NOT REFRIGERATED DURING TRANSPORTATION OR STORAGE."

Additional Manufacturer Narrative

E.1: COMPLAINANT STREET ADDRESS: (b)(6) BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092, MANUFACTURING SITE: 3005778470.