DR FOG TREATED SPONGE, STERILE

Description of Event or Problem

COMPLAINANT ALLEGES "STERILIZED SEAL FAILURE".

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, BUT PICTURES OF THE DEVICE AND PACKAGING WERE PROVIDED. A SPONGE WAS CAUGHT IN THE PACKAGE SEAL, PREVENTING A FULL SEAL ON THE PRODUCT. THIS IS MOST LIKELY DUE TO MANUAL POUCH LOADING OR MOVEMENT OF THE FOAM DURING THE SEALING PROCESS. THE ROOT CAUSE IS MANUFACTURING ERROR. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.