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Model Number TECR1510 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Purulent Discharge (1812); Erythema (1840); Fistula (1862); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Discomfort (2330); Injury (2348); 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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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.Concomitant medical products: tecr1510 parietex rigid py 15x10cm x1 (lot# sgd00370).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.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced infected mesh, recurrence, purulent fluid, wound infection, abscess, skin was erythematous, inflammation, and fistula.Post-operative patient treatment included revision surgery, removal of infected mesh, incision and drainage of abscess, and repair of recurrent left inguinal hernia with alloderm mesh.The device was used with an unknown tacker.
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Event Description
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The patient's attorney alleged a deficiency against the device.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced infected mesh, recurrence, purulent fluid, wound infection, abscess, skin was erythematous, inflammation, pain, scarification, mesh encapsulation, lack of adequate ingrowth, and fistula.Post-operative patient treatment included revision surgery, removal of infected mesh, incision and drainage of abscess, and repair of recurrent left inguinal hernia with alloderm mesh.The device was used with an unknown tacker.
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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.Product was used for laparoscopic therapeutic treatment of a bilateral inguinal hernia.It was reported that after implant, the patient experienced seroma, tenderness, sinus tract, scarring, infected mesh, recurrence, purulent fluid, wound infection, abscess, skin was erythematous, inflammation, pain, scarification, mesh encapsulation, lack of adequate ingrowth, and fistula.Post-operative patient treatment included medication, revision surgery, removal of infected mesh, incision and drainage of abscess, and repair of recurrent left inguinal hernia with alloderm mesh.Concomitant device: unknown tacker.
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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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Search Alerts/Recalls
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