TYCO HEALTHCARE UK MANF. LTD MESH BALLYMONEY - IVS TUNNELLER¿; MESH, SURGICAL, POLYMERIC
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Model Number IVS02 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Bacterial Infection (1735); Erythema (1840); Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Rash (2033); Urinary Tract Infection (2120); Ulcer (2274); Urinary Frequency (2275); Discomfort (2330); Fungal Infection (2419); Prolapse (2475); Dysuria (2684); Fluid Discharge (2686); Constipation (3274); 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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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 implant, the patient experienced prolapse, urgency, pain, abdominal pain, urinary tract infection, ulcerated cystocele, dyspareunia, incontinence, urinary frequency, nocturia, vaginal discomfort, constipation, dysuria.
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Manufacturer Narrative
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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.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.The product was used for therapeutic treatment.It was reported that after implant, the patient experienced prolapse, urgency, pain, abdominal pain, urinary tract infection, ulcerated cystocele, dyspareunia, incontinence, urinary frequency, nocturia, vaginal discomfort, constipation, dysuria, positive for candida; enterococcus; st aphylococcus aureus; escherichia coli; yeast; & streptococcus group b, atrophic vulva, tenderness, urinary leakage, large cystocele looks red, discharge, thrush like rash, infected cystocele, & bleeding.Post-operative patient treatment included number 76 pessaryinserted/removed, gelhorn pessary inserted, ring pessary removed, uti medication, hospitalization, & daily vaginal packing.
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Manufacturer Narrative
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(patient codes, ime e2402: atrophic vulva) 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.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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