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Model Number PCO3020OSX |
Device Problem
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); Emotional Changes (1831); Unspecified Infection (1930); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Impaired Healing (2378); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191); 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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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 incisional hernia.It was reported that after implant, the patient experienced severe pain, hernia recurrence, adhesions, fibrosis, scarring, mesh with portions of edematous, congested, and fibromembranous tissue, abdominal abscess, infected and draining sinuses with minimal purulence.Post-operative patient treatment included removal surgery.The product had been used with an unknown securestrap device.
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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 hernia.It was reported that after implant, the patient experienced infected mesh, open wound, severe pain, hernia recurrence, adhesions, fibrosis, scarring, mesh with portions of edematous, congested, and fibromembranous tissue, abdominal abscess, infected and draining sinuses with minimal purulence.Post-operative patient treatment included removal surgery, infected mesh removal, wound vac, and abdominal washout.The product had been used with an unknown securestrap device.
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Manufacturer Narrative
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Patient codes: c64343(fibromembranous tissue, congested).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 incisional hernia.It was reported that after implant, the patient experienced infected mesh, open wound, severe pain, hernia recurrence, adhesions, fibrosis, scarring, mesh with portions of edematous, congested, seroma, fibromembranous tissue, abdominal abscess, infected and draining sinuses with minimal purulence.Post-operative patient treatment included removal surgery, infected mesh removal, wound vac, abdominal debridgement, and abdominal washout.
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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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Additional info: a4, b5, h6 (patient codes, imf 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.The product was used for therapeutic treatment of a recurrent incisional hernia.It was reported that after implant, the patient experienced muscle weakness in abdomen, depression, loss of enjoyment of life, digestive problems, bloating, soreness, infected mesh, open wound, severe pain, hernia recurrence, adhesions, fibrosis, scarring, mesh with portions of edematous, congested, seroma, fibromembranous tissue, abdominal abscess, infected and draining sinuses with minimal purulence.Post-operative patient treatment included medication, wound debridement, hernia repair with new mesh, exploratory laparotomy, lysis of adhesions, egd, removal surgery, infected mesh removal, wound vac, abdominal debridgement, and abdominal washout.
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Search Alerts/Recalls
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