التفاصيل - تيقظ

الرقم المرجعي

الشركة الصانعة

اسم الجهاز الطبي

الأجهزة المتأثرة

الممثل المعتمد

سبب المشكلة

الإجراء التصحيحي

Medtrade Products has produced a revised IFU contains the following changes, the attachment is to provide the information prior to the new IFU being available.

- Warning:
"This product contains chitosan derived from shellfish; clinicians should exercise caution with individuals with known shellfish allergies".
"Postpartum haemorrhage (PPH) is a severe and multifaceted condition requiring the coordinated use of various medical interventions, in very rare instances, patients have reported transient disturbances in vision and auditory function. While no definitive causal relationship to specific treatments has been established, any occurrence of these symptoms warrants prompt medical evaluation and management"

-Continue using the product as intended in accordance with IFU with the additional warnings identified in the attachment until the updated IFU becomes available
-Monitor for any sign and symptoms related to the reported effect and report any suspected adverse events.

Manufacturer's Action: Instructions and Correction.

المرفقات

مسجل لدى هيئة الحكومة الرقمية برقم:

SA-10-11-25-1137