| The Composix Kugel Mesh patch, manufactured | | | | • PC # 0010208 Bard Composix Kugel Extra |
| by Davol, Inc., a subsidiary of CR Bard, is a | | | | Large Oval 7.7 "x 9.7" |
| medical device that is used to repair ventral | | | | • PC # 0010209 Bard Composix Kugel Oval 6.3 |
| hernias caused by thinning or stretching of scar | | | | x 12.3 " |
| tissue that usually occurs after hernia surgery. | | | | • PC # 0010202 Bard Composix Kugel Large |
| These tissue that is already delicate and sensitive, | | | | Oval 5.4 "x 7" |
| and after serious medical procedures is the even | | | | • PC # 0010204 Bard Composix Kugel large |
| more. They threw the update is inserted into the | | | | circle 4.5 " |
| body behind the hernia area, where the spring | | | | The problem with this defective medical device is |
| loaded plastic memory recoil keep it in place. | | | | so serious that on 24 March 2006 will recall that |
| Unfortunately, there is a significant problem with | | | | the doctors and healthcare professionals: |
| memory recoil ring. In some cases, the memory | | | | "immediately end the use of the specific product |
| ring can break all the way which may lead to an | | | | codes and lot numbers are listed below. Optional |
| intestine perforation or chronic enteric fistulae, or | | | | you can immediately distribute copies of this |
| abnormal relations between the two tissues that | | | | important Patient Management Information to |
| are not normally connected. Further complicating | | | | clinicians that can be implanted or who can deal |
| the potential problems of Composix Kugel Mesh | | | | with patients already implanted with one of these |
| update is that even mild pressure exerted in | | | | products under the voluntary recall. |
| different surgical techniques may lead to it to | | | | Moreover, the FDA recall notice stated: "Patients |
| break and result in potentially serious | | | | who have been implanted with a Composix Kugel |
| consequences. | | | | Mesh update during hernia surgery should seek |
| The Food and Drug Administration and Bard came | | | | medical attention immediately if they experience |
| together to recall a number of defective many | | | | symptoms that may be associated with ring |
| Composix Kugel Mesh Updates because of their | | | | breakage. These symptoms include: unexplained or |
| propensity to commit. There were three different | | | | persistent abdominal pain, fever, soreness at the |
| memories that took place in December 2005, | | | | surgery site or other unusual symptoms. " |
| January 2006 and March 2006 as follows: | | | | The danger of a defective medical equipment that |
| • PC # 0010206 Bard Composix Kugel Extra | | | | Composix Kugel Mesh update will likely continue to |
| Large Oval 8.7 x 10.7 " | | | | influence society for a while. When the public loses |
| • PC # 0010207 Bard Composix Kugel Extra | | | | confidence in medical devices, it is difficult if not |
| Large Oval 10.8 x 13.7 " | | | | impossible to regain. |