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Model Number TEC1309 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Pain (1994); Scar Tissue (2060); Hernia (2240); Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: tec1309 parietex std py 13x9cm x1 (lot#: sqi078x), 174006 protack 5mm disp in (lot#: p6j0716px).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 ventral hernia, an umbilical hernia, and bilateral inguinal hernias.It was reported that after the implant, the patient experienced recurrence, pain, fibrocollagenous scar tissue, and adhesions.Post-operative patient treatment included revision surgery, lysis of adhesions, bilateral transversus abdominis releases, and hernia repair with mesh.Relevant tests/laboratory data: (b)(6) 2019: pathology report from prosthetic mesh removal specimen showed limited associated fibrocollagenous scar tissue (b)(6) 2020: op note stated abdominal ct scan showed hernia in the supraumbilical region containing small bowel.
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Manufacturer Narrative
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Additional info: a4, b5, e1 (facility name, street, city, region, postal code), g1, g3, h6 (added 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 ventral hernia, an umbilical hernia, and bilateral inguinal hernias.It was reported that after the implant, the patient experienced recurrence, pain, fibrocollagenous scar tissue, and adhesions.Post-operative patient treatment included medication, ct scan, revision surgery, lysis of adhesions, bilateral transversus abdominis releases, and hernia repair with mesh.
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Search Alerts/Recalls
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