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Model Number PCO3020X |
Device Problems
Degraded (1153); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Swelling (2091); Thrombosis (2100); Discharge (2225); Discomfort (2330); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); No Code Available (3191); Thrombosis/Thrombus (4440); 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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Manufacturer Narrative
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(b)(4).Incident date was not provided.(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 patient underwent a hernia ventral repair with mesh.The patient had a surgical revision approximately 3 months post op.The patient experienced abdominal wall abscess, foul-smelling drainage, edema, deep vein thrombosis, and infection.
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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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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Event Description
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The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of a ventral hernia.After underlay implant, the patient experienced abdominal wall abscess, foul-smelling drainage, edema, deep vein thrombosis, ileus, abdominal pain, copious amounts of necrotic fat, chronic draining sinus, abdominal swelling, grumous material, infection, abscess, bacterial infection, second layer of mesh entirely unincorporated, (b)(6), and open wound.Post-operative treatment included wound debridement, wound vac, placement of drainage catheter, incision and drainage of abscess, local advancement flap coverage, excision of umbilicus and dissection down to infected mesh, removal of sutures, removal of necrotic fat, and removal of the 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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Event Description
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The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of a ventral hernia.After implant, the patient experienced abdominal wall abscess, foul-smelling drainage, edema, deep vein thrombosis, infection and open wound.Post-operative treatment included wound debridement, wound vac and removal of the mesh.
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Event Description
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The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of a ventral hernia.After underlay implant, the patient experienced abdominal wall abscess, foul-smelling drainage, edema, deep vein thrombosis, ileus, abdominal pain, copious amounts of necrotic fat, chronic draining sinus, abdominal swelling, grumous material, infection, abscess, bacterial infection, second layer of mesh entirely unincorporated, staphylococcus aureus, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, defective device, failure of mesh, and open wound.Post-operative treatment included wound debridement, wound vac, placement of drainage catheter, incision and drainage of abscess, local advancement flap coverage, excision of umbilicus and dissection down to infected mesh, removal of sutures, removal of necrotic fat, and removal of the mesh.
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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.
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Event Description
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The patient's attorney alleged a deficiency against the device.Product was used for therapeutic treatment of a ventral hernia.After underlay implant, the patient experienced adhesions, scarring, abdominal wall abscess, foul-smelling drainage, edema, deep vein thrombosis, ileus, abdominal pain, copious amounts of necrotic fat, chronic draining sinus, abdominal swelling, grumous material, infection, abscess, bacterial infection, second layer of mesh entirely unincorporated, staphylococcus aureus, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, defective device, failure of mesh, and open wound.Post-operative treatment included wound debridement, wound vac, placement of drainage catheter, incision and drainage of abscess, local advancement flap coverage, excision of umbilicus and dissection down to infected mesh, removal of sutures, removal of necrotic fat, ct-scan, and removal of the mesh.Relevant tests/laboratory data (b)(6) 2015: ct scan of the abdomen and pelvis showed a large subcutaneous abscess.Right lower extremity ultrasound showed dvts.(b)(6) : ct scan of abdomen still showed a large anterior abdominal wall abscess without intra-abdominal extension.(b)(6) 2015: microbiology: abdominal wall abscess culture with moderate gram-positive cocci in pairs and clusters, rare gram-negative bacilli.(b)(6) 2016: microbiology: staphylococcus aureus.
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Manufacturer Narrative
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Additional information: b5, e1(facility name), h6(patient codes), additional codes 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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Additional info: b5, h6 (patient codes).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.Product was used for therapeutic treatment of a ventral hernia.After underlay implant, the patient experienced inflammation, scar tissue, adhesions, scarring, abdominal wall abscess, foul-smelling drainage, edema, deep vein thrombosis, ileus, abdominal pain, copious amounts of necrotic fat, chronic draining sinus, abdominal swelling, grumous material, infection, abscess, bacterial infection, second layer of mesh entirely unincorporated, staphylococcus aureus, mental pain, physical pain, suffering, disability, impairment, loss of enjoyment of life, loss of care/comfort/consortium, defective device, failure of mesh, and open wound.Post-operative treatment included wound debridement, wound vac, placement of drainage catheter, incision and drainage of abscess, local advancement flap coverage, excision of umbilicus and dissection down to infected mesh, removal of sutures, removal of necrotic fat, ct-scan, and removal of the mesh.
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Search Alerts/Recalls
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