SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 025 05 15 000
Date submitted:	5/5/2015

Manufacturer:	SHANGAHI CHANNELMED IMPORT & EXPORT CO LTD.
Device Type:	Hot Water Bottle
Description:	Hot Water Bottle 2000ml With Cover // Without Cover
Medical Device Identifier:	Batch Number: ScmhwbOO1 Lot No.: Cj14146 Barcode Number: 6955887301105
Reason of Field Safety Corrective Action:	A Client reported a case to SFDA, that he bought a Hot Water Bag from one of Al Nahdi Pharmacies without IFU. The client then filled the bag with boiling water and lay on it, which caused the bag to explode.
Remedy Action:	Instructions for Use in both Arabic and English will be added in each water bag (Attached).
Athorized Representative/Importer/Distributor:	Nahdi Medical Company
Report Source:	NCMDR
Source Ref. Number:	EE5134EC3A299
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	SHANGAHI CHANNELMED.pdf

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