SFDA National Center for Medical Devices Reporting

X

Your changes have been successfully saved

Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
Home Published FSNs/Recalls About NCMDR Contact Us FAQ Login

NCMDR Recall

Back

Reference Number:	mdprc 122 12 15 000
Date submitted:	12/29/2015

Manufacturer:	Bayer Healthcare LLC.
Device Type:	Nova T 200 IUD
Description:	T-shaped Copper IUD model with 200 mm2 copper surface
Medical Device Identifier:	Nova T copper IUD (T-shaped Copper IUD model with 200 mm2 copper surface) by Bayer. Impacted Batch No. TUO0V5S, TUOOV6Z, TUOOVBE, TUOOWGS, TUOOXVN, TUOOXVS, TUO1OXV, TUO11W6, TUO11W7, TUO13TA, TU014GU, TU014KP, TU0164J
Reason of Field Safety Corrective Action:	An increased device breakage rate for Nova T 200 IUD was observed.
Remedy Action:	Further insertion of IUDs of the affected batches should not be performed. The removal of an already successfully inserted IUD in absence of any symptom or any other reason for removal is not considered justified in view of the potential risk associated with an additional removal and insertion of a new IUD. Planned removals of Nova T 200 should be performed by grasping the removal threads with a forceps and applying gentle traction, as per routine procedure.
Athorized Representative/Importer/Distributor:	AL-KAMAL Import
Report Source:	NCMDR
Source Ref. Number:	EC53CFB166325
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Bayer Healthcare.pdf

View History