Model Number 5196502400 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problems
Erosion (1750); Micturition Urgency (1871); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Dyspareunia (4505)
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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, legal representative stated the patient with this device experienced device extrusion and mixed urinary incontinence.Patient had a partial explantation of the device and a cystoscopy.Interoperative findings noted device extrusion on the left side and device noted to be loose in midline.
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Event Description
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Additional information received on 12/16/2022 as follows: patient has experienced dyspareunia, severe pelvic and vaginal pain, urinary problems and incontinence.
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Event Description
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Additional information received on 1/8/2023 provided the following new details: patient experienced mixed acute and chronic inflammation.
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Search Alerts/Recalls
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