[147051]
According to reporter a letter from fda associate commissioner of legislative affairs to a congressman dated apr 22, 1997 states that for the period 1984-1997, the number of adverse event reports for ostomy products and accessories were insufficient to indicate a problem. Reporter states there is no evidence that the fda had ever solicited the ostomate community to learn of their experience with the prosthesis (ostomy pouch and accessories) upon which their quality of life depends. Reporter asked what sort of info the fda requires to initiate an investigation of a medical device that is a prosthesis, an artificial replacement of a rectum or bladder. Reporter has collected internet postings of horror stories and the mfr reactions. These postings could be verified because the writers' e-mail addresses would be included. Reporter states if fda will address these issues, a great service would be given to approx 1 million citizens with ostomies. It is believed that a majority of the ostomates are elderly; many are in nursing homes and in assisted living facilities. A box of ten (10) of the subject flanges was returned to mfr. It is unused except for the enlarged center hole to receive a stoma. Each of the used flanges resulted in similar catastrophic adhesion failures: flange #1 - within 14 hours the seal separated and did not retain the feces. Flange #2 - within 8 hours the seal separated and did not retain the feces. Flange #3 - within 8 hours the seal separated and did not retain the feces. Flange #4 - within 12 hours the seal separated and did not retain the feces. Flange #5 - within 10 hours the seal separated and did not retain the feces. Flange #6 - within 8 hours the seal separated and did not retain the feces. Flange #7 - was put in place this morning. Flanges #8 & #9 - are being held in reserve until replacements obtained today that may be more reliable. Flange #10 - is enclosed. According to reporter the natura is alleged to be an improved product. Measurements and calculations show that the skin barrier of natura is about 0. 010 inches thinner than the sur-fit. Although the area of the natura is greater than the sur-fit (3" diameter vs 2. 75" diameter) there was sufficient reduction of skin barrier material to make 100 add'l flanges per 1000. And, the increased area of the skin barrier material reduced the area of the surrounding adhesive. Reporter requests that convatec replace the box of defective flanges with effective and reliable flanges of good quality. And that mfr provide the following info to consumers for any product on the open market (except ostomy products). A) state, in writing, the intended purpose of convatec's skin barrier products. B) define the limitations of (convatec's) skin barrier products by revealing their performance characteristics. C) release (convatec's) skin barrier quality assurance procedures so that the user or a third party can verify performance characteristics, if they choose to do so. D) provide documented assurances that today's purchase of (convatec's) skin barrier product(s) are the same product(s) purchased last month or last year and how the consumer is made aware of a change.
Patient Sequence No: 1, Text Type: D, B5