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 total number of events for product classification code pag is (b)(4).Pelvilace biourethral support system 2 needles introducers, (b)(4) disposable handle, (b)(4) tissue connectors, 1.5cm x 50cm porcine acellular collagen matrix sling.(b)(4) - pelvilace biourethral support system needle and implant hook needle 50cm.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.Sample not received.
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The patient's attorney alleged a deficiency against the device.Per additional information received, the patient has experienced incomplete bladder emptying (urinary retention), pain, extrusion, infection, unspecified urinary problems, recurrence, bleeding and additional surgical intervention.
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