Dura patches recalled

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Dura patches recalled

Postby razzle51 » Sat Jun 02, 2007 11:39 am

EnDura No-React Dural Patches Recalled Due to Sterility Concerns

Yael Waknine
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Assess clinically focused product information on Medscape.
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May 30, 2007 — All EnDura No-React dural substitute products (Shelhigh, Inc; distributed by Integra Neurosciences) have been recalled due to sterility and other manufacturing concerns, the US Food and Drug Administration (FDA) announced yesterday. The patches are used during closure of dura mater in neurosurgery.

The class 1 recall follows a public health notification issued to the company on May 2, 2007, citing the environmental controls and processes used to manufacture and test these devices may compromise the sterility and safety of these products, thereby linking their use to a reasonable risk for serious adverse health consequences or death.

All products that may be in the field from the date of first shipment in 2003 to the present are affected, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. These include the 2 x 10 cm (ENR20210), 4 x 4 cm (ENR20404), 5 x 6 cm (ENR20506), 6 x 10 cm (ENR20610), 10 x 12 cm (ENR21012), and 12 cm diameter (ENR21212) patches.

Additional information concerning the recall is available from the company's customer service department by phone at 1-800-456-8482.

Healthcare professionals are encouraged to report adverse reactions related to use of dural substitute products to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
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Postby donbr » Sat Jun 02, 2007 1:03 pm

Roz I am concerened about this, although Heidi's NS didnt need to open the dura he needed to repair a weak spot in the dura, is this done with a patch or somthing else

Postby kathymichelle » Sat Jun 02, 2007 1:06 pm

Don read a copy of the surgical report, should have the material used in the surgery.

Dr E should of given a copy to you, double check that...

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Postby donbr » Sat Jun 02, 2007 3:03 pm

No he didnt say what product he used but after rereading the post she isnt having any adverse effects from any of the surgeries shes had so she should be ok but i will remember about the recall just for referance.
Wouldnt want any ns to do brain surgery just to find out everything is ok

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