Model Number 5196502400 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Inflammation (1932); Nerve Damage (1979); Pain (1994); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Anxiety (2328); Abdominal Cramps (2543); Hematuria (2558); Dysuria (2684); Paresthesia (4421); Kidney Infection (4502); Unspecified Kidney or Urinary Problem (4503); Dyspareunia (4505)
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Event Type
Injury
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Event Description
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As reported to coloplast, though not verified, the legal representative for the patient stated patient was diagnosed with pudendal nerve damage due to ongoing pelvic pain, abdominal pain, and pain with intercourse.The device was explanted in 2020 and the patient continues to experience pudendal nerve pain, vaginal pain, pelvic pain, painful intercourse, urinary problems and requires ongoing medical care for her painful device-related conditions.
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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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Additional information received on 11/13/2022 and 11/22/2022 provided the following information: in addition to previously reported symptoms the patient is experiencing chronic inflammation, urinary retention, hematuria and dysuria, abdominal pain, muscle spasm/disorder, urinary tract infections, anxiety, and tingling in bilateral legs.
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Event Description
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Additional information received on 8/7/2023 provided new patient symptoms of thick yellow discharge observed.
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Search Alerts/Recalls
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