NATURA

Additional Manufacturer Narrative

DEVICE 6 OF 15. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. 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 REPORTED THAT FIFTEEN WAFERS' OPENINGS WERE OFF CENTERED FROM TWO BOXES WITH THE SAME LOT NUMBER. HE DID NOT USE THEM; HOWEVER, HE REPORTED THAT HE WAS VERY FRUSTRATED THAT THIS ISSUE HAD BEEN REPORTED BEFORE AND HE DECLINED TO USE AS WHEN HE HAD IN THE PAST, THE FLANGE CAUSED RUBBING OF THE STOMA DUE TO THE PROXIMITY OF THE STOMA TO THE FLANGE. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.