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Model Number P100510 |
Device Problems
Migration or Expulsion of Device (1395); Product Quality Problem (1506); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Edema (1820); Fistula (1862); Foreign Body Reaction (1868); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Scar Tissue (2060); Discharge (2225); Hernia (2240); Peritonitis (2252); Injury (2348); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Fibrosis (3167); No Code Available (3191)
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Event Type
Injury
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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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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 recurrent umbilical hernia.It was reported that after implant, the patient experienced strangulated incisional hernia, drainage of chronic sinus tract, adhesions, incarcerated and strangulated small bowel, necrotic abdominal wound status post closed loop obstruction, bowel had a dusky appearance, scar tissue, ascites, abdominal wall abscess, chronic wound with exposed bowel, omentum densely adherent to anterior abdominal wall, transverse colon was densely adherent, small bowel obstruction, loops of small bowel densely adherent, twisting and torsion of bowel, thickened area of mesentery and small bowel in jejunum, mesh on the right side was shrunken and wrinkled, non-healing surgical wound sequela, purulent material in sinus tract, and infected mesh.Post-operative patient treatment included umbilical hernia repair, removal of umbilicus, wound closure, incisional hernias repaired with sutures, lysis of adhesions, resection of necrotic small bowel, released of bowel from hernia sac, debridement of exudate in superior portion of wound, debridement of skin necrosis, subcutaneous tissue, fat, necrotic muscle and fascia as well as recurrent ventral hernia repair with small bowel obstruction (partial) repair with mesh, abdominal wall reconstruction, placement of drains, excision of skin and subcutaneous tissue, repair of abdominal hernia, old scar tissue was removed, interloop adhesions were lysed, portions of a previous mesh were also removed, incision and drainage of large fluid collection, subcutaneous tissue, and abdominal wall abscess, excisional debridement of abdominal wall, recurrent incisional hernia repair with mesh, adhesions of entire anterior abdominal wall were taken down, recurrent defect repaired with sutures, small bowel resection was performed, mesentery defect was closed with sutures, removal of intra-peritoneal mesh, sinus tract was excised in its entirety, and removal of infected intra-abdominal mesh.
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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 a recurrent umbilical hernia.It was reported that after implant, the patient experienced strangulated incisional hernia, a fistula, mesh migration, drainage of chronic sinus tract, adhesions, incarcerated and strangulated small bowel, necrotic abdominal wound status post closed loop obstruction, bowel had a dusky appearance, scar tissue, ascites, abdominal wall abscess, chronic wound with exposed bowel, omentum densely adherent to anterior abdominal wall, transverse colon was densely adherent, small bowel obstruction, loops of small bowel densely adherent, twisting and torsion of bowel, thickened area of mesentery and small bowel in jejunum, mesh on the right side wasshrunken and wrinkled, non-healing surgical wound sequela, purulent material in sinus tract, and infected mesh.Post-operative patient treatment included umbilical hernia repair, removal of umbilicus, wound closure, incisional hernias repaired with sutures, lysis of adhesions, resection of necrotic small bowel, released of bowel from hernia sac, debridement of exudate in superior portion of wound, debridement of skin necrosis, subcutaneous tissue, fat, necrotic muscle and fascia as well as recurrent ventral hernia repair with small bowel obstruction (partial) repair with mesh, abdominal wall reconstruction, placement of drains, excision of skin and subcutaneous tissue, repair of abdominal hernia, old scar tissue was removed, interloop adhesions were lysed, portions of a previous mesh were also removed, incision and drainage of large fluid collection, subcutaneous tissue, and abdominal wall abscess, excisional debridement of abdominal wall, recurrent incisional hernia repair with mesh, adhesions of entire anterior abdominal wall were taken down, recurrent defect repaired with sutures, small bowel resection was performed, mesentery defect was closed with sutures, removal of intra-peritoneal mesh, sinus tract was excised in its entirety, wound vac, and removal of infected intra-abdominal mesh.
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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: h6 (added patient code, removed code a0201), notified date, ch notified date.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 recurrent incisional umbilical hernia.It was reported that after implant, the patient experienced recurrence, a fistula, mesh migration, drainage of chronic sinus tract, adhesions, incarcerated and strangulated small bowel, necrotic abdominal wound status post closed loop obstruction, bowel had a dusky appearance, scar tissue, ascites, abdominal wall abscess, chronic wound with exposed bowel, small bowel obstruction, twisting and torsion of bowel, thickened area of mesentery and small bowel in jejunum, mesh on the right side was shrunken and wrinkled, non-healing surgical wound sequela, purulent material in sinus tract, inflammation, foreign body reaction, peritonitis, hemorrhage, edema, fibrotic hernia sac, serositis, and infected mesh.Post-operative patient treatment included umbilical hernia repair, removal of umbilicus, wound closure, incisional hernias repaired with sutures, lysis of adhesions, resection of necrotic small bowel, released of bowel from hernia sac, debridement of exudate in superior portion of wound, debridement of skin necrosis, subcutaneous tissue, fat, necrotic muscle and fascia as well as recurrent ventral hernia repair with small bowel obstruction (partial) repair with mesh, abdominal wall reconstruction, placement of drains, excision of skin and subcutaneous tissue, repair of abdominal hernia, old scar tissue was removed, interloop adhesions were lysed, portions of a previous mesh were also removed, incision and drainage of large fluid collection, subcutaneous tissue, and abdominal wall abscess, excisional debridement of abdominal wall, recurrent incisional hernia repair with mesh, adhesions of entire anterior abdominal wall were taken down, recurrent defect repaired with sutures, small bowel resection was performed, mesentery defect was closed with sutures, removal of intra-peritoneal mesh, sinus tract was excised in its entirety, wound vac, and removal of infected intra-abdominal mesh.
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Search Alerts/Recalls
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