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Model Number BRD200S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Erosion (1750); Calcium Deposits/Calcification (1758); Cyst(s) (1800); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Pain (1994); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Disability (2371); Prolapse (2475); Dysuria (2684); Fluid Discharge (2686); Dyspareunia (4505); Urinary Incontinence (4572)
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Event Type
Injury
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Manufacturer Narrative
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Adverse events: complications associated with the proper implantation of the align® urethral support system may include, but are not limited to: "postoperative hematoma, which may occur following the implant procedure, temporary urinary retention, bladder outlet obstruction, voiding difficulties associated with over-correction/too much tension placed on the mesh sling implant, perforations or lacerations of vessels, nerves, bladder or any viscera, which may occur during introducer needle passage, transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection and erosion of the implant." (b)(4).Report is late due to the fda ¿exemption of (b)(6) transition period.(b)(4) june 27, 2019 sample not received.
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Event Description
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The patient¿s attorney alleged a deficiency against the device.Per additional litigation received, the patient has experienced pain, injury, disability and impairment.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Per additional information received on 04jun2021, the patient experienced severe pain, dyspareunia, inability to walk normally, mesh erosion, bleeding, recurrent incontinence, urethral mesh exposure, stress urinary incontinence, ovarian cyst, pelvic trauma, recurrent vaginal or bladder infections, recurrent vaginal pain, urethral diverticulum, unspecified urethral stricture, lesion, cystitis, urinary frequency, mixed urinary incontinence, urine leakage, urge incontinence, urethral reconstruction, chronic overactive bladder syndrome, calculus of kidney, urinary tract infection, hydronephrosis, chronic dysuria, severe urethral hypermobility, first degree cystocele, abdominal pain, prolapse and required additional surgical and non-surgical interventions.
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Event Description
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Per additional information received via medical records on 21apr2023, the patient has experienced urethral stricture, eroded mesh in the urethra, urethral diverticulum, stress urinary incontinence, urethral mesh exposure and required additional non-surgical treatments.
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Manufacturer Narrative
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2371, 1685, 1799, 1871, 2686, 1758, 2120, 2684, 2475 =nl.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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