My son has had a cecostomy tube for many years, with no issues.We started using the amt miniace around a year ago with no problems.We routinely changed his amt miniace button on (b)(6) 2022.On (b)(6) 2022 the balloon failed.We had the same issue with 3 devices.I have repeatedly reached out to amt and sent the defective buttons to be analyzed.We have had recent similar issues with their gastrostomy buttons.There is no reason this many buttons should fail with no clear reason.We are not the only family having this issue.This needs to be investigated.It is a serious issue when the balloons fail because the buttons can become dislodged, it effects the ability for the individual to complete their antegrade continence enema, it can cause trauma to the site if the stoma shrinks and needs to be dilated to replace the failed button.Not to mention the cost to continue to replace these medically necessary devices, that should ideally last 3 to 6 months.The lots we had balloon failures in are: amt mini ace, ref ace-1027, lot 210927-236 10f 2.7cm, placed 7/2/2022 to 8/13/2022; amt mini ace, ref ace-1027, lot 220408-072 10f 2.7cm, placed 8/13/22 to 8/23/2022; amt mini ace, ref ace-1027, lot 220601-593 10f 2.7cm, placed 8/23/22 to 9/6/2022.Fda safety report id# (b)(4).
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