THE PRODUCT IS SUPPLIED WITH THE EXPIRATION DATE CLEARLY LABELED. THE DEVICE EXPIRED IN 6/2016. A REVIEW OF RECORDS SHOWS THAT THE DEVICE WAS SUPPLIED TO THE USER FACILITY IN 2014. THIS EVENT IS CONFIRMED FOR USE RELATED. THE IFU INSTRUCTS THE USER "DO NOT USE PROGEL? PALS AFTER THE EXPIRATION DATE, BECAUSE STERILITY OR PERFORMANCE MAY BE COMPROMISED." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. USED ON PATIENT.
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Patient 1
IT WAS REPORTED THAT AN EXPIRED PROGEL SEALANT WAS USED ON A PATIENT. FOLLOWING THE INITIAL APPLICATION, THE PROGEL DID NOT WORK. THE SURGEON WAS TOLD THE PRODUCT WAS EXPIRED. THE PHYSICIAN ASKED FOR A SECOND SEALANT, FLOSEAL, TO COMPLETE THE PROCEDURE. NO OTHER INTERVENTION WAS RENDERED EXCEPT FOR THE APPLICATION OF FLOSEAL. THE PATIENT WAS REPORTED AS DOING FINE AND NOT HAVING ANY PROBLEM.