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 135 10 18 000
Date submitted:	10/24/2018

Manufacturer:	Medtronic SA
Device Type:	Parietex Composite Parastomal Mesh
Description:	Mesh, Polymeric
Medical Device Identifier:	Item Code: PCOPM15, PCOPM20 Affected lots: See lots listed on Attachment A
Reason of Field Safety Corrective Action:	Medtronic states that it has received reports of the above mesh failing several years after parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, the mesh failure led to hernia recurrence and necessitated additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin.
Remedy Action:	Identify, isolate, and discontinue use of any affected product in your inventory. Return affected products to Medtronic or your distributor.
Athorized Representative/Importer/Distributor:	Medtronic Saudi Arabia
Report Source:	BfArM
Source Ref. Number:	A31518(ECRI), 12882/18
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic.pdf

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