التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Recommendations for Healthcare Providers: 
Healthcare providers who have treated patients using the subject device and who have identified potential device fragments left in a patient (e.g. through post-biopsy imaging) should:
- Inform the patient of the issue and potential risks.
- Assess the significance based on clinical findings and risk of complications.
- Determine the appropriate clinical management (i.e. conservative monitoring in the asymptomatic patient or, if indicated clinically, surgical removal).
- Continue to provide routine follow-up care ensuring that the patient has clear instructions on seeking further treatment (signs & symptoms that may indicate complications).


Actions to be taken by all users:
1. Do not use Brevera® Breast Biopsy System Disposable 9 Gauge Needles.
2. Please segregate and count how many units of the subject product are currently in your inventory.
3. Please quarantine all units of the subject product.
4. Please return all affected units to Hologic.

Manufacturer's action: Instructions and Removal.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-22-01-26-1234