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.
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As reported to coloplast, though not verified, subject experienced purulent vaginal discharge on (b)(6) 2016 resulting in inpatient hospitalization and surgical procedure on (b)(6) 2016.During procedure, the restorelle df posterior device was partially explanted at the posterior vaginal wall and apex.
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