ESTEEM

Additional Manufacturer Narrative

E1: NAME OF AFFILIATION: (B)(6). BRAND NAME OF DRUG USED FOR URINARY TRACT INFECTION (UTI): BACTRIM DOUBLE STRENGTH (DS) 800/160. H6: IMDRF CLINICAL SIGNS- HEALTH EFFECT -CLINICAL CODE - E0309 FOR LOW WHITE BLOOD CELL COUNT WHICH IS NOT AVAILABLE FOR SELECTION. THE EVENT IS CONSIDERED AS MISUSE SINCE THE END USER WAS NOT WASHING HIS HANDS AND CUTTING OUT ANTI-REFLUX VALVE OF THE PRODUCT WHICH IS NOT RECOMMENDED. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A SERIOUS INJURY. THIS COMPLAINT HAS BEEN EVALUATED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE, THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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: 9618003.

Description of Event or Problem

THE END USER ATTRIBUTED THE USE OF COMPANY'S POUCH TO THE DEVELOPMENT OF A URINARY TRACT INFECTION (UTI), AS THE POUCH FILM VACUUMED TO THE STOMA. THE PRODUCT SPECIALIST HAD ADVISED THE NURSE TEAM TO CONTACT THE END USER BECAUSE THE END USER STATED THAT THE COMPANY'S PRODUCT HAD CAUSED HIS UTI. THE END USER HAD A NEW UROSTOMY AND WAS DISCHARGED WITH ANOTHER BRAND. THE NURSE HAD ADVISED THAT THIS OTHER BRAND WAS THE BEST TO PREVENT UTI PRIOR TO HIM TRIALING COMPANY'S PRODUCT. HE DECIDED TO TRIAL THE COMPANY'S PRODUCT AND STATED THAT WITHIN TWO WEEKS, HE HAD DEVELOPED A UTI. HE STATED THAT THE PHYSICIAN DID NOT ATTRIBUTE IT TO THE COMPANY'S POUCH AND NO CULTURE WAS PERFORMED. THE END USER STATED THAT THEY COULD NOT PROVE IT WAS COMPANY'S PRODUCT, BUT HE CONSIDERED IT "UNDER SUSPICION". THE PATIENT WAS DIAGNOSED DUE TO SYMPTOMS WHICH INCLUDED BLOOD IN URINE, FOUL ODOR IN URINE, CHILLS (NO FEVER), TINGLING IN PERISTOMAL AREA (NO FLANK PAIN). HIS SYMPTOMS HAD RESOLVED AND THE URINE HAD CLEARED AFTER THE TREATMENT. HE WAS TREATED WITH SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH (DS) 800/160 BID (TWICE A DAY) FOR TEN DAYS. HIS SYMPTOMS HAD RESOLVED AND THE URINE HAD CLEARED. HE NOTED HE HAD BEEN CUTTING OUT THE ANTI-REFLUX VALVE IN THE COMPANY'S POUCH AT THE RECOMMENDATION OF HIS LOCAL OSTOMY NURSE, AND HE HAD NOTED LESS MUCUS IN HIS URINE SINCE DOING THIS. HE BELIEVED THE DESIGN OF THE COMPANY'S SYSTEM WAS FAULTY, CREATING A VACUUM EFFECT WITH THE POUCH FILM, AND THE VALVE TAP DID NOT PREVENT URINE FROM GETTING ON HIS HANDS. IT WAS DISCUSSED THAT CUTTING OUT THE ANTI-REFLUX MECHANISM WAS NOT A RECOMMENDED PRACTICE BY THE COMPANY. ADDITIONALLY, HAND HYGIENE BEFORE AND AFTER WAS DISCUSSED, AND THE END USER ADVISED THAT HE DID NOT FIND IT CONVENIENT BEFORE AND HAD NOT BEEN DILIGENT IN DOING THIS. NO PHOTO IS AVAILABLE AT THIS TIME.