Model Number 5196502400 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Skin Erosion (2075); Genital Bleeding (4507)
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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, that the patient with this device experienced mesh erosion, exposed mesh, painful surgical intervention to remove the exposed and eroded mesh.
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Event Description
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Additional information received further reported that the patient experienced vaginal atrophy, introitus tenderness, and intermittent vaginal bleeding.The patient was going to be treated with vaginal estrogen and resection.
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Manufacturer Narrative
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D4 lot number: 54002451.
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Search Alerts/Recalls
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