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Model Number UNK PELVICOL |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Micturition Urgency (1871); Incontinence (1928); Irritation (1941); Urinary Tract Infection (2120); Urinary Frequency (2275); Injury (2348); Prolapse (2475)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.Product was used for therapeutic treatment.The preoperative and postoperative diagnosis was stage 3 pelvic organ prolapse with large cystocele and stress urinary incontinence.The procedure performed was an anterior colporrhaphy with mesh and a tension-free vaginal tape with mesh, and cystoscopy.The patient underwent an additional procedure on (b)(6) 2006.The preoperative and postoperative diagnosis was vaginal vault prolapse with enterocele and rectocele.The procedure performed was an abdominal colposacropexy with mesh, posterior colporrhaphy, and cystoscopy.The patient underwent an additional procedure on (b)(6) 2012.The preoperative and postoperative diagnosis was symptomatic rectocele and vaginal vault prolapse.The procedure performed was a bilateral sacrospinous ligament fixation and posterior colporrhaphy with xengraft.At this time a xenoform soft tissue repair mesh, cat: 830-247, lot: 1107012, serial: (b)(4), exp.: 5/1/14 was implanted.The patient returned for an office visit on (b)(6) 2012 for a postoperative visit.The patient was doing well but still had some minor urgency/frequency and rare urge incontinence.The patient returned for an office visit on (b)(6) 2015 for urinary incontinence.The previous sling appeared to be palpable and appeared to have migrated away from the mid urethral and over the urethrovesicle junction.It was not painful and there was not mesh erosion.The patient underwent an additional procedure on (b)(6) 2015.The preoperative and postoperative diagnosis was recurrent stress urinary incontinence and recurrent rectocele.The procedure performed was a posterior colporrhaphy, excision of previous sling, and placement of obtryx halo sling and cystoscopy.At this time a boston scientific sling microvasive uphold obtryx transobturator halo, model: m00068505000, lot: ml00002751, exp.: 11/1/17 was implanted.The patient returned for an office visit on (b)(6) 2015.The patient was till leaking.
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Manufacturer Narrative
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Corrected date: h7 modification adjustment selected in error.No action was to be selected.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Per additional information received, the patient¿s post-bard implantation history is remarkable for extensive adhesive disease, recurrent vaginal vault prolapse with enterocele and rectocele with abdominal colposacropexy with bard mesh and posterior colporrhaphy, urinary tract infection, urogenital atrophy treated with vagifem, recurrent stress urinary incontinence and recurrent vaginal vault prolapse and rectocele and underwent bilateral sacrospinous ligament fixation and posterior colporrhaphy with boston scientific xenograft on (b)(6) 2012.She continued to suffer from minor urgency and frequency, recurrent stress urinary incontinence requiring her to wear pads and resulting in vulvar irritation, and recurrent rectocele.On (b)(6) 2015 she underwent posterior colporrhaphy, excision of previous sling (mesh) that was felt to have ¿migrated up past the urethrovesical junction and was sitting at approximately the level of the trigone¿, and placement of boston scientific obtryx tot halo sling.Per additional information received, the patient required additional surgical intervention.
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Manufacturer Narrative
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Corrected information: sex, date of birth, no eval explain code.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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