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
Erosion (1750); Pain (1994); Deformity/ Disfigurement (2360); Dyspareunia (4505); Sexual Dysfunction (4510); Urinary Incontinence (4572)
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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 with this device experienced severe pain with daily activities and intercourse.Urinary incontinence, physical deformity and the loss of the ability to perform sexually.
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Event Description
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Additional information received further reported that between (b)(6) 2019 and (b)(6) 2019 the patient had experienced or was experiencing exposed urethral sling midline anterior vaginal wall, brush-like sensation when wiping vagina, severe vaginal pain, and dyspareunia.The patient underwent mesh excision, and cystoscopy with local anesthesia in-office.
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Search Alerts/Recalls
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