NR APBY
AU anonym
TI Import alert IA8403
QU Center for Devices and Radiological Health, Food and Drug Administration, 27.6.87
IA http://www.fda.gov/ora/fiars/ora_import_ia8403.html
VT
IA#84-03 - 6/27/87
BACKGROUND
A recent reported case of Creutzfeldt-Jakob Disease (CJD) in a 28 year-old patient who had received a human dura mater graft indicates that the graft may have been the source of this always fatal disease. The woman died 22 months after receiving the lyophilized, irradiated human cadaveric dura mater graft. The dura mater used in the graft was packaged in October 1982 under lot #2105 by B. Braun Melsungen AG of West Germany, shipped to Tri Hawk International, Inc., Montreal, Quebec, Canada and sold to Saint Francis Hospital, Hartford, Connecticut, on April 4, 1985.
This is the first known case of CJD transmission associated with a dura mater graft. Present methods of sterilizing the dura mater do not completely inactivate the CJD agent.
The dura mater is manufactured by the West German firm under the trade name Lyodura. Although the material is primarily used in neurosurgery, it is also used in orthopedic, otologic, dental, urologic, gynecologic, and cardiac surgical procedures.
We have been unable to determine the total number of packages of Lyodura that were imported into the United States because the Canadian distributor failed to maintain adequate records of distribution for all lots which may have been distributed by mail to hospitals in the United States and Canada.
As stated in the FDA Safety Alert which issued April 28, 1987, we strongly recommend that users of dura mater choose only products from known sources which retrieve, process and handle the material according to guidelines such as those of the American Association of Tissue Banks.
To report cases or for further information, please contact:
Gordon C. Johnson, M.D.
Center for Devices and Radiological Health, Food and Drug Administration
8757 Georgia Ave,
Silver Spring, Maryland 20910
GUIDANCE
Alert your local Customs office to be aware of this import alert and to monitor mail shipments for this product.
Detain all shipments of Lyodura (dura mater) received from Tri Hawk International, Inc., Montreal, Quebec, Canada or from B. Braun Melsungen AG of West Germany. Charge: "The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears to be adulterated under section 501(h), because the methods and controls used for the storage and distribution of Lyodura (dura mater) are not in conformance with current good manufacturing practice requirements under section 520(f)(1)."
IN 22 Monate nachdem ihr eine lyophylisierte, bestrahlte und im Oktober 1982 mit der Nummer 2105 verpackte dura mater (Lyodura) der westdeutschen Firma Braun Melsungen AG implantiert wurde, starb eine 28 Jahrte alte Frau an der Creutzfeldt-Jakob-Krankheit.
SP englisch