Model Number 5014502400 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
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Patient Problems
Adhesion(s) (1695); Bacterial Infection (1735); Foreign Body Reaction (1868); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Urinary Retention (2119); Burning Sensation (2146); Urinary Frequency (2275); Numbness (2415); Prolapse (2475); Hematuria (2558); No Code Available (3191)
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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.
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Event Description
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As reported to coloplast though not verified, patient's legal representative stated foreign body reaction, pain, urinary problems, urinary retention, pressure, pain, inflammation, painful urination, numbness, dyspareunia, difficulty voiding, difficulty emptying bladder, burning sensation, infections and other injuries.
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Manufacturer Narrative
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This follow-up mdr is created to document the additional patient, event, and device information and lot review.H6 patient code (b)(6) selected due to a code not available for urethral kink.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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Event Description
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Additional information reported to coloplast indicated the patient experienced urinary frequency and urinary urgency.Significant elevation of the urethrovesical junction resulting in kinking of the urethra was reported.A procedure was performed on january 26, 2018 to resolve this urethra kink.A mild cystocele and nocturia were later noted.
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Manufacturer Narrative
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This follow-up mdr is created to document the additional event information.H6 patient code 3191 selected due to a code not available for urethral kink, feels small vaginal bulge and nocturia coloplast has not been provided any corroborating evidence to verify the information contained in this report.
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Event Description
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As reported to coloplast though not verified, additional information stated on 07/17/2017 - patient unable to urinate after foley removed.Pvr 357 ml.Instructed to cic.(b)(6) 2017 - patient able to void on own but has worsening urinary frequency, urgency, and urge urinary incontinence.Nocturia 3-4 times nightly.She reports with her leakage episodes she can feel a bulge in her vagina.Physical exam reveals a stage 2 recurrence of cystocele.Bid intermittent catheterization (b)(6) 2017 - urinary retention, pvr 596 ml, urine culture positive for e.Coli (b)(6) 2017 - hospitalization for acute pyelonephritis, sepsis (e.Coli), urinary retention - pvr 400 ml.Ct showed urothelial thickening in the right renal collecting system, which may be seen with pyelitis.(b)(6) 2018 - urinary retention requiring intermittent self-catheterization, urinary frequency/ urgency.Urodynamics - normal, in-office cystoscopy - normal.Stage 2 elevation in urethrovesical junction resulting in kinking of urethra, urinary retention/voiding dysfunction secondary to position of restorelle direct fix/coloplast distal arms, pvrs 200-300 mls cytopathology report benign.(b)(6) 2018 - revision of mesh and urethrolysis under general anesthesia.Intraoperative findings: restorelle direct fix/coloplast incorporated in bladder wall at urethrovesical junction with urethral adhesions.Pathology showed foreign body giant cell reaction with mild chronic inflammation (b)(6) 2018 uti (klebsiella pneumoniae) with hematuria.Self-catherization prn if pvr >150 ml.(b)(6) 2018 - pelvic pressure / burning and mild cystocele (b)(6) 2018 - urinary urgency/nocturia/splatter with high output, back pain/pressure, feels small vaginal bulge and grade 1 cystocele (b)(6) 2018-(b)(6) 2019 - improving intermittent urinary retention, nocturia, grade 2 cystocele, microhematuria.The patient reported a burning sensation after the device was explanted.
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Search Alerts/Recalls
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