|
Model Number BRD200S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Micturition Urgency (1871); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Pain (1994); Hernia (2240); Prolapse (2475); Constipation (3274); Urinary Incontinence (4572)
|
Event Type
Injury
|
Manufacturer Narrative
|
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.".
|
|
Event Description
|
It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, suffering, disability and impairment.
|
|
Manufacturer Narrative
|
2475, 1914, 1908, 2240, 3274, 1928, 1871, 2371 = "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.
|
|
Event Description
|
Per additional information received via medical records on 30mar2022, the patient has experienced pain, chronic pelvic pain, urinary problems, urgency and painful urination, mesh migration, stress urinary incontinence, chronic constipation, hernias, hypertension, hypotension, vaginal pain, infections, uterine prolapse, vaginal vault prolapse, obstructive voiding and required additional surgical and non-surgical interventions.
|
|
Search Alerts/Recalls
|
|
|