Model Number 5196502400 |
Device Problem
Device Appears to Trigger Rejection (1524)
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Patient Problems
Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Urinary Tract Infection (2120); Prolapse (2475); Kidney Infection (4502); 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, the patient experienced mesh erosion, mesh extrusion, bladder an kidney infections, dyspareunia, pain, foreign body reaction an other injuries.
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Event Description
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Additional information received further reported that in (b)(6) 2019 the patient underwent a robotic assisted halban's procedure, bilateral uterosacral vault suspension, cystoscopy, and bilateral salpingectomy under general anesthesia.Recurrent prolapse with enterocele.In (b)(6) 2020 the patient underwent removal of the altis mesh, axis anterior repair with biologic graft, sacrospinous ligament fixation, and cystoscopy.Vaginal pain at vaginal sling insertion site, recurrent anterior prolapse.
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Search Alerts/Recalls
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