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Model Number BRD100R |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Pain (1994); Anxiety (2328); Cramp(s) /Muscle Spasm(s) (4521); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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).No sample received.
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Event Description
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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.
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Event Description
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As per medical records received on 03-jan2024, the patient experienced vaginal pain, cramping, diabetes, hypertension, urinary incontinence, stress urinary incontinence, acid reflux, low potassium, anxiety, and post-traumatic stress disorder, cystocele, mesh erosion, mesh protruding per vagina and required additional surgical and non-surgical treatments.
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Manufacturer Narrative
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1994, 2371, 2193, 1908, 1928= "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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