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Model Number P101015 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Perforation (2001); Scar Tissue (2060); Seroma (2069); Vomiting (2144); Hernia (2240); Abdominal Distention (2601); 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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(b)(4).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.It was reported that after implant, the patient experienced recurrence, adhesions, scarring, seroma, abdominal pain, abdominal wall bursa, inflammation, and foreign body giant cell reaction.Post-operative patient treatment included abdominal wall reconstruction and removal of mesh.
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Manufacturer Narrative
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Additional info: h6 (patient codes, imf codes, device code, ime e2402 updated to include: "allergic reaction").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.It was reported that after implant, the patient experienced pain, infection, hematoma, perforation, nausea, vomiting, allergic reaction, abdominal bloating, bulging recurrent hernia, recurrence, adhesions, scarring, seroma, abdominal pain, abdominal wall bursa, inflammation, and foreign body giant cell reaction.Post-operative patient treatment included medication, revision surgery, incision and drainage, abdominal wall reconstruction, evacuation and debridement, partial explant surgery, resection of abdominal wall bursa with quilting progressive tension suture reconstruction ablation, removal of mesh and hernia repair with new mesh.
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Search Alerts/Recalls
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