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تسجيل جديد
الخميس - صفر 27, 1447
مسجل لدى هيئة الحكومة الرقمية برقم:
20250728714
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EN
SA-27-02-25-796
التفاصيل
الرقم المرجعي
الشركة الصانعة
اسم الجهاز الطبي
ProPort™ Plastic Implantable Ports
الأجهزة المتأثرة
Item Number: 21-4151-24 , 21-4152-24, 21-4153-24 , 21-4155-24, 21-4171-24, 21-4172-24, 21-4173-24 , 21-4183-24 Lot Number: Refer to Appendix A in the attachment.
الممثل المعتمد
AL MADAR MEDICAL SERVICES COMPANY
سبب المشكلة
The plastic port housing and port reservoir of the ProPort™ Plastic Implantable Ports may separate because of a manufacturing defect.
الإجراء التصحيحي
- As instructed in the IFU, continue to monitor patients who have an implanted ProPort™ Implantable Ports for signs of any adverse events. - As instructed in the IFU, ensure the housing and reservoir feel secure and stable when palpating the portal. Symptoms such as swelling, redness, or discomfort at the implant site may indicate leakage or system failure. - Check all inventory locations within your institution for the impacted lot numbers listed in the attachment (Appendix A) and discontinue use. Destroy all affected products following your institution’s process for destruction. If destroying is not immediately possible at your facility, then the product should be quarantined until disposal. Manufacturer action: Instructions and Removal.
المرفقات
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