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Patient 1
ON (B)(6) 2015, THE IRVINE SCIENTIFIC, QUALITY AND TECHNICAL SUPPORT SCIENTIST WAS INFORMED BY OUR IRVINE SCIENTIFIC TERRITORY MANAGER THAT HE HAD VISITED A CUSTOMER, THE SCIENTIFIC DIRECTORY AT A FERTILITY CENTER AND THAT THEY HAD A FEW CASES OF CRYO TIPS EXPLODING WHEN THEY TRANSFERRED THEM INTO A WATERBATH TO THAW (WARM) THEM. THESE EVENTS OCCURRED AS FOLLOWS: CRYO TIP LOT #40709 T094 (MANUFACTURE DATE: JANUARY 14, 2015, EXPIRATION DATE: FEBRUARY 4, 2017) THAWED ON (B)(6), 2015. CRYO TIP LOT #40709 T071A (MANUFACTURE DATE: AUGUST 2, 2012, EXPIRATION DATE: SEPTEMBER 14, 2014) THAWED ON (B)(6), 2015. CRYO TIP LOT #40709 T073A (MANUFACTURE DATE: JUNE 19, 2012, EXPIRATION DATE: NOVEMBER 26, 2014) THAWED ON (B)(6), 2014. ON (B)(6), 2015, THE IRVINE SCIENTIFIC TECHNICAL APPLICATION SPECIALIST (TAS) SPOKE TO THE CUSTOMER TO REVIEW THE EVENTS THAT WERE REPORTED. THE TAS REVIEWED THE LOADING AND SEALING OF THE SPECIMENS IN THE CRYO TIP. THE TAS OFFERED TO VISIT THE CUSTOMER TO REVIEW THEIR SEALING PROCEDURE AND IT WAS DECLINED BY THE CUSTOMER. AS A RESULT IRVINE SCIENTIFIC IS FILING THIS MDR WITH AN ABUNDANCE OF CAUTION. THIS MDR SUBMISSION IS OUR INITIAL AND FINAL REPORT. A F/U REPORT WILL BE SUBMITTED.