The contract manufacturer reviewed the lot 1003027 & 1003028 dhr and stated specifications were met.Review of lot # for complaint trend, nonconforming report and capa review.No trends noted.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 or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
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According to the information provided by health (b)(6) pain in the lower back and down hips to the bottom of the legs, pain in the right groin and right thigh still numb, difficulty walking.Drug taken for the bladder to avoid slenderness because if forgotten there is big slenderness.Pain in my stomach.No resistance a few months ago but had to reduce working hours due to difficulty working a full day.
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