SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO3728 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Cellulitis (1768); Cyst(s) (1800); Inflammation (1932); Scar Tissue (2060); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); Fibrosis (3167); No Code Available (3191)
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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 ventral hernia.It was reported that after the implant, the patient experienced recurrence, adhesions, and bladder injury.Post-operative patient treatment included revision surgery, debridement of fascia and area around previous mesh, a bladder repair due to injury from mesh, recurrent hernia repair, adhesiolysis, and excision of mesh.
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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 the implant, the patient experienced recurrence, adhesions, open wound, pockets of gas with cellulitis or phlegmon formation in fat, inflammation, fibrosis, fluid collection, urachal remnant, mesh migration, abscess, draining sinus, muscular diastasis, urachal cyst, scar tissue, and bladder injury.Post-operative patient treatment included revision surgery, debridement of fascia, bladder repair, recurrent hernia repair with new mesh, adhesiolysis, multiple hernia sacs excised, hospitalization, myofascial flaps, left and right rectus muscles, destruction of urachal cyst, removal of prior suture material, and mesh removal.
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Manufacturer Narrative
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Additional information: patient codes - c64343 ( pockets of gas, urachal remnant, muscular diastasis ).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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