Model Number 5014202400 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Erosion (1750); Foreign Body Reaction (1868); Pain (1994); Urinary Incontinence (4572)
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Event Type
Injury
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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 severe pelvic pain, foreign bodies in her bladder, and urinary incontinence.A doctor performed an additional surgery to remove pieces of the device that had eroded into her bladder to avoid any further damage.
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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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Manufacturer Narrative
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Correction: item number, udi number.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.
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Event Description
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Additional information received on 12/18/2022 as follows: on (b)(6) 2017 a prolene suture in the bladder was observed, most likely related to the burch procedure.
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Search Alerts/Recalls
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