Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.See attached letter from fda dated 06/23 indicating fda has determined coloplast no longer qualifies for participation in the asr exemption #(b)(6) program.Effective immediately, we are required to electronically submit individual adverse event reports for these product codes.
|