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Catalog Number 482150 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erosion (1750); Unspecified Infection (1930); Scarring (2061)
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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 potential complications: complications associated with the proper implantation of the pelvilace biourethral support system may include, but are not limited to: postoperative hematoma.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage.(b)(4) 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.(b)(4) the total number of events for product classification code page is 12.Qty 4- pelvilace biourethral support system 2 needles introducers, 1 disposable handle, 4 tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.Qty 2- pelvilace to biourethral support system.Qty 6- pelvilace biourethral support system needle and implant hook needle 50cm.
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Event Description
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The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced pelvic discomfort, hypotension, recurrence, extrusion, pain, erosion, infection, unspecified urinary problems, dyspareunia, blood loss, mixed and stress urinary incontinence, bladder neck defect, blood loss, nocturia, dribbling, leaking urine with coughing/laughing/sneezing/bearing down/walking/standing/physical exertion, first degree cystocele (prolapse), vaginal scarring (scarring), blood tinged urine (hematuria), vaginal spotting, drainage, vaginal wall wound (vaginal mucosa damage), vaginal wall defect, feels wire inside vaginal wall (foreign body sensation), sleepiness and required additional surgical and non-surgical interventions.
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Manufacturer Narrative
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(b)(4).Original reporting time frame september 1, 2015 to october 31, 2015.
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Manufacturer Narrative
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(b)(4).Original reporting time frame (b)(4) 2015.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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Manufacturer Narrative
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(b)(4).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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Manufacturer Narrative
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(b)(4).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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Search Alerts/Recalls
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