Nortrade Medical.Nortrade Medical, Sandy, UT, May 26 (Denver). Information on product labels, literature and the company's Web site were false and misleading, misbranding Burnfree Pain Relieving Gel, Sterile Burn Dressing and Hydrogel hy·dro·gel n. A colloidal gel in which the particles are dispersed in water. hydrogel a gel that contains water. hydrogel Wound care A polymer absorptive wound dressing. See Dressing. Survival Fire/Trauma Blankets, FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. stated. The letter said claims for preventing infection, lessening pain and being "non-irritating" and "bacteriostatic bacteriostatic /bac·te·rio·stat·ic/ (bak-ter?e-o-stat´ik) inhibiting growth or multiplication of bacteria; an agent that so acts. " were uncleared. In addition, the claim for "use on all types of burn injuries" exceeded the 510(k), which covered use only for first and second degree burns. Investigator Juan Morales Juan Morales Hechevarria (born July 12, 1948) is a former Cuban athlete who competed mainly in 110 metres hurdles. Together with Hermes Ramírez, Pablo Montes, and Enrique Figuerola he won an Olympic silver medal in 4 x 100 metres relay in Mexico City 1968. collected related in-formation Jan. 15 and 25 and Feb. 23. |
|
|||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion