NATURA

Additional Manufacturer Narrative

MDR. / DEVICE 8 OF 8. 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 THE OPENING IN THE EIGHT MOLDABLE SKIN BARRIERS WERE OFF CENTERED WHICH MADE THE SKIN BARRIER UNUSABLE. CONSUMER WAS A LONG-TIME USER OF THIS PRODUCT; TYPICAL WEAR TIME WAS FIVE DAYS. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.