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Model Number UNK SURGIPRO MESH |
Device Problems
Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Purulent Discharge (1812); Emotional Changes (1831); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Ulceration (2116); Hernia (2240); Ulcer (2274); Discomfort (2330); Injury (2348); Impaired Healing (2378); Ascites (2596); Abdominal Distention (2601); Bowel Perforation (2668); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); 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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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.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced significant adhesions, chronic constipation, mesh sharply opened, adhesions stuck to the mesh, infected mesh, loop of small bowel, recurrence and open wound.Post-operative patient treatment included hernia repair with mesh and sutures, removal of mesh, small bowel resection as well as incision was irrigated and a wound vac was placed over the infected incision.
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Manufacturer Narrative
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(removed c64343) 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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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target 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 incisional hernia.It was reported that after implant, the patient experienced significant adhesions, chronic constipation, mesh sharply opened, infected mesh, recurrence, open wound, purulent drainage, cellulitis, abscess, chronic inflammation, fibrosis of the serosal surface, focal ulceration, scar tissue, multiloculated fluid collection, and discomfort.Post-operative patient treatment included hernia repair with mesh and sutures, removal of mesh, total colectomy with an ileorectal anastomosis, appendectomy, small bowel resection as well as incision was irrigated and a wound vac was placed over the infected incision and placement of baxter bioscience veritas.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.Additional information: b5, g4 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 incisional hernia.It was reported that after implant, the patient experienced significant adhesions, chronic constipation, mesh sharply opened, adhesions stuck to the mesh, infected mesh, loop of small bowel, recurrence and open wound.Post-operative patient treatment included hernia repair with mesh and sutures, removal of mesh, small bowel resection as well as incision was irrigated and a wound vac was placed over the infected incision and placement of baxter bioscience veritas.
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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 incisional hernia.It was reported that after implant, the patient experienced significant adhesions, mesh failure, defective device, pain, purulent fluid collection, bowel entered due to adhesions, chronic constipation, infected mesh, recurrence, open wound, purulent drainage, cellulitis, abscess, chronic inflammation, fibrosis of the serosal surface, focal ulceration, scar tissue, multiloculated fluid collection, mental and physical pain, disability, impairment, loss of enjoyment of life, and discomfort.Post-operative patient treatment included hernia repair with mesh and sutures, removal of mesh, total colectomy with an ileorectal anastomosis, appendectomy, small bowel resection, incision was irrigated, wound vac was placed over the infected incision, primary repair of hernia, mesh revision, adhesiolysis, and placement of baxter bioscience veritas.
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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 incisional hernia.It was reported that after implant, the patient experienced draining sinus, bulging, significant adhesions, mesh failure, defective device, pain, purulent fluid collection, bowel entered due to adhesions, chronic constipation, infected mesh, recurrence, open wound, purulent drainage, cellulitis, abscess, chronic inflammation, fibrosis of the serosal surface, focal ulceration, scar tissue, multiloculated fluid collection, mental and physical pain, disability, impairment, loss of enjoyment of life, and discomfort.Post-operative patient treatment included ct scan, medication, exploratory laparotomy, hernia repair with mesh and sutures, removal of mesh, total colectomy with an ileorectal anastomosis, appendectomy, small bowel resection, incision was irrigated, wound vac was placed over the infected incision, primary repair of hernia, mesh revision, adhesiolysis, and placement of baxter bioscience veritas.
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Search Alerts/Recalls
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