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Model Number 0112660 |
Device Problems
Defective Device (2588); Extrusion (2934)
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Patient Problems
Erosion (1750); Pain (1994); Prolapse (2475)
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Event Date 02/21/2006 |
Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The medical records provided indicated the patient experienced pain, erosion and prolapse.A manufacturing review was performed which found no anomalies during the manufacturing process of the device.With the current information available, no definitive conclusion can be made.If additional event and/or evaluation information is obtained, a follow up mdr will be submitted.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.Not returned to manufacturer.
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Event Description
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The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2004 - the patient was diagnosed with cystocele, enterocele, rectocele and moderate sigmoid pelvic adhesions.The patient underwent an abdominal sacrocolpopexy with implant of a bard flat mesh and two non-bard davol "titanium screws with polypropylene sutures.On (b)(6) 2005 - the patient was diagnosed with extrusion of vaginal mesh at the vaginal apex.The patient was thought to previously have some mild vaginal mesh erosion at the apex of her vagina and used vaginal estrogen over three months with mild improvement in symptoms, but continued to have vaginal pain and the sensation of something at the very top of her vagina that was painful with intercourse.The patient opted for surgical excision, with a vaginal approach.The patient underwent a partial explant of the bard flat mesh along with 2 polypropylene sutures.Per op details "inspection revealed the extruded mesh at the very apex of the vagina.This was grasped with an allis, pulled down, and excised with scissors.The area was carefully inspected and 2 of the polypropylene sutures that were noted to be in the area were also excised." on (b)(6) 2006 - the patient was diagnosed with vaginal mesh extrusion, suture extrusion and mild cystocele.The patient underwent a partial explant of the bard flat mesh, removal of the non-bard davol sutures and implant of a non-bard davol mid-urethral sling.Per the op report details "what was seen extruding was on blue prolene suture which was grasped, cut and removed in its entirety.Another prolene suture was encountered and removed as well as some of the mesh in the area.".
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Search Alerts/Recalls
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