The 2 incidents with bard silicone foley, size 10fr and 12fr.Placed intraoperatively.The balloon of 10 fr deflated and foley dislodged from patient requiring another placement undersedation, replaced with 12fr - which also dislodged, and patient was brought back for another placement under sedation.The attending physician examined both products once removed from the patient and found there were very small holes in the silicone balloon causing a slow leakage of fluid from the balloon.Ref# 165812; lot# ngen4736 company representative also made aware of issues: (b)(6).Fda safety report id # (b)(4).
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