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Catalog Number 486100 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Anemia (1706); Asthma (1726); Erosion (1750); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Failure of Implant (1924); Incontinence (1928); Itching Sensation (1943); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Scar Tissue (2060); Abnormal Vaginal Discharge (2123); Vomiting (2144); Hernia (2240); Urinary Frequency (2275); Anxiety (2328); Injury (2348); Depression (2361); Disability (2371); Obstruction/Occlusion (2422); Prolapse (2475); Intermenstrual Bleeding (2665); Foreign Body In Patient (2687); Dyspareunia (4505); 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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The sample was not returned.The finished product met all specifications prior to being released for general distribution.The instructions for use which accompanies all devices currently addresses potential risks associated with surgically implanted materials.The instructions for use states in the adverse events: ¿complications associated with the proper implantation of the avaulta solo¿ synthetic support may include, but are not limited to those typically associated with surgically implantable materials, including: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding and defecatory dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, rectum, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of vaginal wall prolapse.Urinary incontinence (stress and urge)." 1994 = "l", 2348, 2371, 2993 = "nl".
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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 injury, pain, disability and impairment.Product was used for therapeutic treatment.Per additional information received, the patient has experienced uterovaginal prolapse, enterocele, urinary urgency, chronic pelvic/vaginal pain, mesh embedded into vaginal tissue (foreign body in patient), scar tissue, scarring, incontinence, bleeding, pain during sexual relations, depression, anxiety, bowel obstruction, irritable bowel syndrome, hernias, hypotension/low blood pressure, obesity, cramps, pulling sensation in vagina and required additional surgical interventions.Per additional information received, the patient has experienced prolapse, incontinence, pelvic pain, bleeding, pain during sexual relations, depression, anxiety, pain, bleeding in vagina during sexual relations (intermenstrual bleeding), bowel obstruction, cystocele/rectocele (prolapse), hernias, hypotension/low blood pressure, anemia, recurrent vaginal pain, severe piercing cramps (cramp), pulling sensation (foreign body sensation), urinary incontinence, vaginal vault prolapse, failed mesh (failure of implant), and required nonsurgical interventions.Per additional information received via medical records, the patient has experienced menstrual irregularities, vaginal discharge, itching, abdominal pain, vomiting, hemorrhage, erosion, and required surgical interventions.
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Manufacturer Narrative
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2475, 1871, 2375 = "l".2687, 2060, 2061, 1928, 2597, 2361, 2328, 2422, 2564, 2240, 1914, 2193, 2665, 2275, 1750, 2144, 1970, 1943, 2225, 2517, 1924, 1869= "nl".H11:section a through f - the information provided by bard 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 bard.
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Event Description
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Per additional information received via medical records on 06oct2020, the patient has experienced menstrual irregularities, vaginal discharge, itching, abdominal pain, vomiting, hemorrhage, erosion, and required surgical interventions.Per additional information received via medical records on 20apr2022, the patient has experienced vaginal pain and bleeding, chronic pelvic pain, dyspareunia, urinary urgency, urgency urinary incontinence, rectal bulge, and urinary frequency.
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Event Description
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Per additional information received via medical records on 14jun2022, the patient has experienced urgency of urination, vaginal atrophy, urgency incontinence, high-tone pelvic floor dysfunction, exposure of implanted vaginal mesh and prosthetic material in vagina, sequela, nocturia, fecal smearing, post coital bleeding, pelvic pain and dyspareunia.
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Manufacturer Narrative
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H11:section a through f - the information provided by bard 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 bard.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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Manufacturer Narrative
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Correction: a,g.1685, 1706, 1726, 1888, 1959, 2519, 2357, 3191= "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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Event Description
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Per additional information received via medical records on 14dec2023, the patient had experienced bladder leaking, uterine prolapse, bowel obstruction, incontinence, pelvic pain, vaginal bleeding, pain during sexual relations (dyspareunia) and rectal pain, depression, anxiety, anemia, asthma, menorrhagia, metrorrhagia, dysmenorrhea, vaginal pain, vaginal atrophy, vaginal mesh exposure, frequency, fecal smearing, post coital bleeding, urge urinary incontinence, stress, sexual dysfunction, genital pain and required additional surgical and non-surgical treatments.
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Search Alerts/Recalls
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