Coloplast has not been provided any corroborating evidence to verify the information contained in this report.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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As reported to coloplast, though not verified, the patient with this device experienced foreign body reaction, pain, dyspareunia, difficulty voiding, difficulty emptying her bladder, burning sensation, infections and other unspecified injuries.It is unknown if or how the patient received treatment for these complications and if the device remains implanted.
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