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FDA MAUDE
米国不具合報告検索
openFDA が公開する米国の医療機器不具合報告データベース（MAUDE）を検索できます。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
取得日: 2026.09.12
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
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期間はデフォルトで直近 1 年（2025-09-12 〜 2026-09-12）を表示しています。
| No. | 受理日 | 事象タイプ | ブランド名 | 製品問題 | 企業名 |
|---|---|---|---|---|---|
| 1 | 2026-08-21 | 不具合 | DUODERM | Delivered as Unsterile Product、Contamination /Decontamination Problem | ConvaTec Dominican Republic Inc |
| 2 | 2026-08-21 | 不具合 | DUODERM | Delivered as Unsterile Product、Contamination /Decontamination Problem | ConvaTec Dominican Republic Inc |
| 3 | 2026-08-21 | 不具合 | DUODERM | Delivered as Unsterile Product、Contamination /Decontamination Problem | ConvaTec Dominican Republic Inc |
| 4 | 2026-08-21 | 不具合 | DUODERM | Delivered as Unsterile Product、Contamination /Decontamination Problem | ConvaTec Dominican Republic Inc |
| 5 | 2026-08-21 | 不具合 | MiniMed 780G US System BLE Connect 3.0 mg/dL | Excess Flow or Over-Infusion、Insufficient Flow or Under Infusion | Medtronic Puerto Rico Operations Co. |
| 6 | 2026-08-21 | 不具合 | MiniMed 780G US System BLE Connect 3.0 mg/dL | Insufficient Flow or Under Infusion | Medtronic Puerto Rico Operations Co. |
| 7 | 2026-08-21 | 不具合 | FreeStyle Libre 2 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 8 | 2026-08-21 | 不具合 | FreeStyle Libre 3 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 9 | 2026-08-21 | 不具合 | FreeStyle Libre 2 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 10 | 2026-08-21 | 不具合 | FreeStyle Libre 2 | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 11 | 2026-08-21 | 不具合 | FreeStyle Libre 3 | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Ltd |
| 12 | 2026-08-21 | 不具合 | FreeStyle Libre 3 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 13 | 2026-08-21 | 不具合 | FreeStyle Libre 2 | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 14 | 2026-08-21 | 不具合 | FreeStyle Libre 3 | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Ltd |
| 15 | 2026-08-21 | 不具合 | FreeStyle Libre 2 | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 16 | 2026-08-21 | 不具合 | FreeStyle Libre 3 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 17 | 2026-08-21 | 不具合 | FreeStyle Libre 3 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 18 | 2026-08-21 | 不具合 | FreeStyle Libre 2 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 19 | 2026-08-21 | 不具合 | FreeStyle Libre 2 Plus | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
| 20 | 2026-08-21 | 不具合 | FreeStyle Libre 2 | Incorrect, Inadequate or Imprecise Result or Readings | Abbott Diabetes Care Inc |
約 2,815,419 件中 1–20 件を表示（件数は概算値です）