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Model Number UNKNOWN PARIETEX |
Device Problems
Material Deformation (2976); Material Integrity Problem (2978); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Emotional Changes (1831); Headache (1880); Unspecified Infection (1930); Inflammation (1932); Muscle Weakness (1967); Nausea (1970); Pain (1994); Scar Tissue (2060); Hernia (2240); Distress (2329); Discomfort (2330); Abdominal Distention (2601); Constipation (3274); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 of a ventral hernia.It was reported that after implant, the patient experienced pain, abdominal pain, adhesions, inflammation, bowel problems, infection, suffering, mental anguish, mental pain, emotional distress, discomfort, defective device, mesh failure, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included revision surgery, mesh removal, and mesh revision.
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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.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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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.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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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced pain, eventration, diastasis, constipation, nausea, swelling, mesh shrinkage, pain with bowel movement, emotional problems, digestive problems, abdominal pain, adhesions, inflammation, bowel problems, infection, suffering, mental anguish, mental pain, emotional distress, discomfort, defective device, mesh failure, disability, impairment, and loss of enjoyment of life.Post-operative patient treatment included revision surgery, mesh removal, and mesh revision.
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Manufacturer Narrative
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H6 (patient codes, ime e2402: abnormal white blood cell count; hemoglobin; hematocrit).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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Event Description
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The patient¿s attorney alleged a deficiency against the device.The product was used for a laparoscopic therapeutic treatment of a ventral hernia.It was reported that after implant, the patient experienced pain, mesh eventration, rectus diastasis, constipation, nausea, swelling, mesh shrinkage, pain with bowel movement, emotional problems, digestive problems, abdominal pain, adhesions, inflammation, bowel problems, infection, suffering, mental anguish, mental pain, emotional distress, discomfort, defective device, mesh failure, disability, impairment, loss of enjoyment of life, abnormal white blood cell count; hemoglobin; hematocrit, bulge, pain triggered migraines, scar tissue.Post-operative patient treatment included revision surgery, mesh removal, mesh revision, ct scan, pain medication, hospitalization, iv fluids, nausea medication, exploratory laparotomy, primary repair of hernia.
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Search Alerts/Recalls
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