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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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بحث عن منتج
تقديم بلاغ
أسئلة شائعة
تواصل معنا
EN
SA-04-08-25-989
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
SKULL TRACTION TONG LARGE
الأجهزة المتأثرة
Model: FF870R Unique Device Identifier (UDI-DI): 403923900000290738
الممثل المعتمد
Gulf Medical CO LTD
سبب المشكلة
It was identified that the Instructions for Use (IFU) did not include essential information regarding contraindications and application details. As a result, this critical information was not made available to the end user.
الإجراء التصحيحي
The Instruction for Use (IFU) TA009782 has been updated (Change No. AE0065363) accordingly with the following changes in content: 2.1.2 Intended use: The skull traction tong is used for odontoid fractures with non-lethal dislocation. It provides temporary immobilization and/or reduction in the transitional region of an unstable cervical spinal injury, as well as for de compression of the spinal cord or nerve roots secondary to spinal misalignment. 2.1.4 Absolute contraindications: - Patients with open fontanelles - Malformations or known reduction of the bone tissue, in particular temporal bone malformations 2.1.5 Relative contraindications: The following conditions, individual or combined, can lead to delayed healing or compromise the success of the operation: - Medical or surgical conditions (e.g., comorbidities) that could hinder the success of the operation. - Children less than 5 years of age - Patients with local sepsis - Patients who are not awake, alert, and cooperative - Skull fractures and particular cervical spine injuries (in particular unstable injuries rostral to the target level, traumatic disc herniations and definitive, complete ligamentous injuries at any cervical spine level). In the presence of relative contraindications, the user decides individually regarding the use of the product. The new elFU is published at https://eifu.bbraun.com Manufacturer Action: Instructions and Correction.
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