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Model Number URETEXTO2 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Patient Device Interaction Problem (4001)
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Patient Problems
Erosion (1750); Fistula (1862); Incontinence (1928); Pain (1994); Hernia (2240); Ulcer (2274); Injury (2348); Disability (2371); Prolapse (2475); Hematuria (2558); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Manufacturer Narrative
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Medtronic complaint report: (b)(4).Reporting period january 1, 2018 through february 28, 2018 summarized events on attached spreadsheet for pro-code otn = 99 uretexto - 3 uretexto2 - 32 uretexto3 - 6 uretexsup - 58 asr report attached.If information is provided in the future, a supplemental report will be issued.
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Event Description
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(b)(4).
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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment.It was reported that after the implant, the patient experienced injury, pain, disability, perineum quite low, urethral mesh erosion, vaginal mesh erosion, pelvic organ prolapse, ulceration, hematuria, large posterior compartment defect with rectocele, cystocele, urethral fistula, rectal prolapse, vaginal bulge, pelvic pressure, urinary incontinence, urethrovaginal fistula, hernia, enterocele, central loss of the posterior floor of the urethra, and impairment.Post-operative patient treatment included excision of suburethral mesh erosion and excision of intraurethral mesh with repair of urethrotomy, urethral augmentation with surgisis biodesign (4x7), partial sling resection, closure of abdominal wall hernia, retropubic space exploration with partial excision of prior retropubic synthetic sling, application of floseal, abdominal sacrocolpopexy, posterior colpoperineorrhaphy, posterior urethral wall reconstruction, vaginal epithelial tubularization for urethral reconstruction, autologous rectus fascia sling, sutures removed, martius fat pad graft (right), and cystourethroscopy.
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Manufacturer Narrative
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Additional information: a2(dob), b5, b6, b7, d4(expiration date), d8, e1 (first name, last name, facility name, street 1, city, region, postal code, phone number), e3, g1 (manufacturer name, mfr contact first name, last name, email, phone number), g3, g4(pma/510(k), h6 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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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Search Alerts/Recalls
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