Model Number 5196502400 |
Device Problems
Material Erosion (1214); Material Protrusion/Extrusion (2979)
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Patient Problem
Skin Erosion (2075)
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Event Type
Injury
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Manufacturer Narrative
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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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According to available information, the patient with this device experienced erosion with extrusion of mesh vaginally.The patient was you and well estrogenized without other risk factors.No other adverse patient effects were reported.
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Event Description
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Additional information received further reported that the physician adjusts her approach when implanting altis.The physician implants in a more retropubic positioning, with sling placement to 11 o'clock and 1 o'clock positions, not the recommended 10 o'clock and 2 o'clock positions.It was noted that this differing placement was not necessarily due to patient anatomy.
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Search Alerts/Recalls
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