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Model Number PCO2015X |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Emotional Changes (1831); Erythema (1840); Fever (1858); Fistula (1862); Foreign Body Reaction (1868); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Pain (1994); Rash (2033); Scar Tissue (2060); Seroma (2069); Hernia (2240); Distress (2329); Discomfort (2330); Impaired Healing (2378); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); 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 an umbilical hernia.It was reported that after implant, the patient experienced pain, discomfort, inflammation, infection, adhesions, recurrence, mental pain, emotional distress, disability, impairment, loss of enjoyment of life, defective mesh.Post-operative patient treatment included revision surgery, removal of mesh.
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Manufacturer Narrative
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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 an umbilical hernia.It was reported that after implant, the patient experienced pain, discomfort, inflammation, infection, adhesions, recurrence, mental pain, emotional distress, disability, impairment, loss of enjoyment of life, abscess, fistula, foreign body reaction, seroma, fibrosis, open draining wound, constipation, abdominal pain, drainage, altered diet, scarring, and defective mesh.Post-operative patient treatment included revision surgery, open excision of sinus, advanced skin flap, wound vac, omentectomy, laparotomy, incision and drainage, hernia repair with new mesh, and removal of mesh.
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Manufacturer Narrative
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Additional info: b2 (added hospitalization), h6 (patient codes, imf codes, ime e2402: "altered diet, sinus tract, ileus").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.
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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 ileus, pus cavity, erythema, loss of abdominal domain, swelling, rash, itchiness, purulent discharge from midline wound, fever, abdominal cavity wound cultures positive for staph aureus, subcutaneous fluid collection, hematoma, infected sinus tract, pain, discomfort, inflammation, infection, adhesions, recurrence, mental pain, emotional distress, disability, impairment, loss of enjoyment of life, abscess, fistula, foreign body reaction, seroma, fibrosis, open draining wound, constipation, abdominal pain, drainage, altered diet, scarring, and defective mesh.Post-operative patient treatment included ct scan, procedure for infected sinus tract, procedure for subcutaneous abscess, procedure for recurrent midline hernia and abscess, exploratory laparotomy, wound exploration with drainage of pus cavity, omentectomy, antibiotics, hospitalization, revision surgery, open excision of sinus, advanced skin flap, wound vac, omentectomy, laparotomy, incision and drainage, hernia repair with new mesh, and removal of mesh.
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Search Alerts/Recalls
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