Model Number 5195512400 |
Device Problem
Material Erosion (1214)
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Patient Problems
Emotional Changes (1831); Pain (1994); Skin Erosion (2075); Deformity/ Disfigurement (2360); Dyspareunia (4505); Urinary Incontinence (4572)
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Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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As reported to coloplast, though not verified, the patient with this device experienced lateral erosion of the surgical mesh, dysphrenia and required excision of the surgical mesh.
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Manufacturer Narrative
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This complaint was investigated to the extent information was provided to coloplast.Due to the legal nature of this complaint and the device not being returned for evaluation a thorough investigation could not be executed.Should additional information become available, this file will be re-evaluated and updated according to current procedures.Complaints of this nature are monitored and captured within the product risk documentation.No further action or corrective action is required at this time.
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Event Description
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The patient with this device experienced severe pain with daily activities and intercourse.The patient suffered severe emotional pain and injury inclusive of painful personal injuries such as urinary incontinence, physical deformity, and the loss of the ability to perform sexually.
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Search Alerts/Recalls
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