The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were 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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As reported to coloplast though not verified, legal representative stated a revision was required of vaginal mesh erosion under general anesthesia.¿anterior vaginal mucosa was evaluated, just behind the urethrovesical junction area, there was approximately about [sic] a 7 x7 mm erosion right in the midline with some exposed vaginal mesh.¿ preoperative diagnosis: "midline mesh erosion from midurethral sling.".
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