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Model Number P152030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Unspecified Infection (1930); Necrosis (1971); Injury (2348); Impaired Healing (2378); Post Operative Wound Infection (2446); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4): revision.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.Preoperative and postoperative diagnosis was recurrent ventral incisional hernia, incarcerated, chronic abdominal pain secondary to toe hernia and chronic panniculitis.The procedure performed was bilateral myofascial advancement flap for abdominal wall reconstruction an component separation technique hernia repair x2, incarcerated recurrent ventral incisional hernia repair with component separation technique and mesh placement, placement of hernia mesh, panniculectomy, intraabdominal adhesiolysis x1 hour and removal of previous abdominal wall mesh.The patient experienced multiple surgical revisions, debridement surgery, non-healing wound surgery, adhesions, and infections.
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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 ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, infection, nonhealing surgical wound.Post-operative patient treatment included revision surgery, debridement of nonhealing surgical wound, non-healing wound surgery, skin graft placement and wound vac therapy.
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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 ventral incisional hernia.It was reported that after implant, the patient experienced adhesions, infection, necrosis and nonhealing surgical wound.Post-operative patient treatment included revision surgery, debridement of skin and subcutaneous tissue of nonhealing surgical wound, non-healing wound surgery, component separation, skin graft placement and wound vac placed.
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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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Search Alerts/Recalls
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