تسجيل الدخول
تسجيل جديد
الأحد - ربيع الأول 8, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
عن تيقظ
بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-28-08-24-574
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
Allurion Device / Elipse Gastric Balloon System
الأجهزة المتأثرة
Reference Number: 10D Lot Number: N/A- no impact to specific lot
الممثل المعتمد
Farouk Mamoun Tamer and Co
سبب المشكلة
Allurion is aware that in rare instances patients may be admitted to a facility that is different from where the balloon was placed. Although the clinical staff the facilities placing the device are trained on the optimal least invasive management of certain conditions, the clinical staff in the facilities where the patient may seek care may not be trained and may opt for more invasive management. Allurion has also identified new contraindications, controls, and precautions around the use of the device. These have incorporated into the updated IFU.
الإجراء التصحيحي
Allurion is releasing key patient management information on the Allurion Balloon, including the proper management of certain rare complications, like GOO or SBOM as well as endoscopic removal of the Allurion Balloon. Allurion is also updating the device IFU to include some important changes. Please refer to the attachment for more information.
المرفقات
عودة للقائمة
