AS WE HAVE NO RECEIVED BACK ANY SAMPLES YET, THE NECESSARY TESTS CANNOT BE MADE. 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 OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED. HOWEVER, A RECHECK OF THE PRODUCT DOCUMENTATION FOR THIS LOT NUMBER DID NOT REVEAL ANY NORM DEVIATION THAT COULD BE RELATED TO THE COMPLAINT. COMPLAINTS SUCH AS THIS IS A NEW ISSUE WITH THIS PRODUCT LINE. THE COMPLAINTS ARE MONITORED CLOSELY FOR A FORMING TREND AND REPORTED TO MANAGEMENT ON A MONTHLY BASIS. PRODUCTION HAS BEEN INFORMED.
D
Patient 1
THE USER HAS SENT A PHOTO BY EMAIL TO THE DISTRIBUTOR AND STATED HE FEARS HE HAS GOT URINARY TRACT INFECTION CAUSED BY OPTIMA URISHEATHS, AS HE HAS FOUND STRANGE RESIDUE/DEPOSIT IN THE SHEATH. THE URISHEATH ON THE PHOTO IS NOT USED. THE USER ACTUALLY IS ON HOLIDAYS, SO WE CANNOT ASK HIM WHETHER HE HAS CONSULTED A DOCTOR OR IF HE TAKES MEDICINE TO TREAT THE INFECTION. THE DISTRIBUTOR WILL ASK HIM ABOUT HIS OUTCOME AND THE TREATMENT AS SOON AS THE USER RETURNED FROM HOLIDAYS. THE ENDUSER IS STILL ON HOLIDAYS AND UNFORTUNATELY HE DOES NOT KNOW WHEN HE WILL BE BACK.