[8081]
Complainant stated she had a urinary ostomy when she was 4 yrs old and has been using this co's urinal pouches, non-rx, for 16 yrs. About 2 yrs ago, co changed mgmt and she noticed firm began using a different type of plastic which she stated had an awful odor. She also noticed the urine collected in the pouches appeared to have a purple haze. In addition, she periodically found hair in the pouches. The complainant stated her stoma attaches to an opening, about 1 cm wide, on the pouch. She observed a purple ink-like substance around the pouch opening, which she believes may be leaching into the bag due to contact with her urine. She is concerned the ink-like substance may go into her stoma. The complainant stated she has switched to another type which collects urine up to a wk. This pouch appears to be a different type of plastic and does not have an odor, according to complainant. The new pouch is white plastic, while the other pouch she was previously using was clear. The clear pouch must be changed approx every day and a half. Complainant purchased products directly from the mfr by mail. Both types of pouches were received in a box and are individually packaged in clear plastic bags and taped. No instructions come in the boxes of pouches and the products are not labeled. In addition, the box in which the pouches come in only have a stick-on label with the firm's name and address. There are no lot numbers either on the pouches or the boxes and the product is not labeled sterile. Complainant has notified firm of purple ink-like substance around opening of pouch. According to complainant, firm does not believe there is a problem. The pouches are marked to point out where the opening is to be made and the width.
Patient Sequence No: 1, Text Type: D, B5