TOROSA

Additional Manufacturer Narrative

THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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 OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO MISLABELING. THE DEVICE WAS NEVER IMPLANTED IN THE PATIENT. UPON COMPARING THE SIZER PICTURED NEXT TO THE FILLED MEDIUM SIZED DEVICE, THE SURGEON BELIEVED THAT THE MEDIUM SIZED DEVICE WAS ACTUALLY A SMALL SIZED DEVICE AND POTENTIALLY MISLABELED AS MEDIUM. ANOTHER DEVICE WAS OPENED AND IMPLANTED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.