Additional Manufacturer Narrative · 1
THE DEVICES WERE NOT RETURNED AND VERY LIMITED INFO WAS PROVIDED BY THE HOSPITAL. ADD'L INFO PROVIDED BY VICE PRESIDENT AND GENERAL COUNSEL: GRAVIDITY/PARITY: G2/P0010 (HX OF 1 TERMINATION). INDICATION FOR THE PROCEDURE: DECREASED MATERNAL EXPULSIVE EFFORT WITH LIMITED PROGRESSION OF THE VERTEX. WHAT KIWI VACUUM DEVICE WAS USED (THE MEDWATCH REPORT LISTS BOTH THE KIWI OMNICUP AND THE VAC-6000S PROCUP): BOTH WERE USED. NUMBER OF PULLS: 5 PER MD AND RN NOTES. NUMBER OF POP-OFFS/DETACHMENTS: NOT DOCUMENTED. WAS THE CUP LOCATION DOCUMENTED AFTER THE DELIVERY? NO. IT APPEARS OUR RECOMMENDATIONS WERE NOT FOLLOWED: IE, 5 PULLS, DID NOT DOCUMENT POP-OFFS, USED BOTH THE PROCUP AND OMNICUP. THERE IS NO EVIDENCE TO SHOW THAT THE KIWI VACUUM CUPS MALFUNCTIONED IN ANY WAY. LOT# 070968.