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Catalog Number 0112650 |
Device Problems
Defective Device (2588); Extrusion (2934); Insufficient Information (3190)
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Patient Problems
Pain (1994); Prolapse (2475); Intermenstrual Bleeding (2665)
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Event Type
Injury
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Manufacturer Narrative
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Currently, it is unknown whether the device may have caused or contributed to the reported event.The attorneys report alleges mesh extrusion.Extrusion is listed in the adverse reaction section of the ifu as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional 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) 2007 - the patient underwent treatment for stress urinary incontinence and repair of enterocele using a non-bard davol capio, xenform and tot via obtryx.On (b)(6) 2007 - the patient was diagnosed with a post hysterectomy vaginal vault prolapse.The patient underwent a transabdominal sacral colpopexy with moschowitz procedure and implant of a bard flat mesh.On (b)(6) 2007 - patient had a post op follow up visit.Patient stated she was doing well postoperatively, however, she did have complaints of urinary incontinence.On (b)(6) 2007 - upon evaluation patient was found to have urethral insufficiency.The patient underwent a tot urethral sling non-bard davol aris (coloplast) repair.There was no mention of the bard flat mesh in the operative details.On (b)(6) 2008 - patient had office visits where the patient was noted to be doing well from a surgical standpoint with no complaints of prolapse.The attorney's claim alleges the patient experienced pain, extrusion of mesh, recurrence, bleeding and urinary problems.
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Search Alerts/Recalls
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