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Model Number P101520 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fungal Infection (2419)
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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 hernia.It was reported that after implant, the patient experienced recurrent/infected mesh, adhesions, recurrent hernia, non-healing wound, wound dehiscence and multiple abdominal ventral hernia defects.Post-operative patient treatment included revision surgery.
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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 large infected abdominal incisional hernia with abscess.It was reported that after implant, the patient experienced recurrent/infected mesh, purulent material, presence of gram-negative bacteria fungus (pseudomonas/telecopier), adhesions, recurrent hernia, small-bowel fistula, non-healing wound, wound dehiscence and multiple abdominal ventral hernia defects.Post-operative patient treatment included removal of infected mesh/sutures/fatty tissue, surgical debridement of wound, primary closure of wound dehiscence in the abdominal incision, lysis of adhesions, and large recurrent ventral incisional hernia repair.
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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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Updated from previous report.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 large infected abdominal incisional hernia with abscess.It was reported that after implant, the patient experienced recurrent/infected mesh, purulent material, presence of gram-negative bacteria fungus (pseudomonas/telecopier), adhesions, recurrent hernia, small-bowel fistula, non-healing wound, wound dehiscence and multiple abdominal ventral hernia defects.Post-operative patient treatment included removal of infected mesh/sutures/fatty tissue, surgical debridement of wound, primary closure of wound dehiscence in the abdominal incision, lysis of adhesions, and large recurrent ventral incisional hernia repair.
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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 large infected ventral incisional hernia with abscess.It was reported that after implant, the patient experienced recurrent/infected mesh, purulent material, presence of gram-negative bacteria fungus (pseudomonas/telecopier), adhesions, recurrent hernia, small-bowel fistula, drainage, non-healing wound, wound dehiscence and multiple abdominal ventral hernia defects.Post-operative patient treatment included removal of infected mesh/sutures/fatty tissue, surgical debridement of wound, primary closure of wound dehiscence in the abdominal incision, incision and drainage, lysis of adhesions, and large recurrent ventral incisional hernia repair with 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: a4, b5, b7, h6 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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Search Alerts/Recalls
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