SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO3020 |
Device Problems
Migration or Expulsion of Device (1395); Material Deformation (2976); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Erosion (1750); Cellulitis (1768); Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); Fibrosis (3167); No Code Available (3191); 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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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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after the implant, the patient experienced infection, recurrence, sinus tract, abscess, mesh migration, mesh was invaginated into the abdominal wall and herniated into defect, adhesions, cellulitis, inflammation, purulent material, erosion through fascia, fibrotic tissue, lack of incorporation, and chronic draining abdominal wound.Post-operative patient treatment included revision surgery, excision of sinus tract, wound exploration/debridement, wound vac, removal of mesh, hernia repair with sutures and mesh, abdominal wall reconstruction, adhesiolysis, admitted to hospital, extensive debridement, abdominal wall reconstruction, bilateral myofascial advancement flaps, and wound irrigation.
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Manufacturer Narrative
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Additional information: b5, e1 (facility name, street 1, city, region, postal code), g1, g3, h6 h6 patient codes - e2402 (sinus tract) 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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after the implant, the patient experienced infection, recurrence, sinus tract, abscess, mesh migration, mesh was invaginated into the abdominal wall and herniated into defect, adhesions, cellulitis, inflammation, purulent material, erosion through fascia, fibrotic tissue, lack of incorporation, pain, exposed and unincorporated mesh, and chronic draining abdominal wound.Post-operative patient treatment included revision surgery, excision of sinus tract, wound exploration/debridement, wound vac, removal of mesh, hernia repair with sutures and mesh, abdominal wall reconstruction, adhesiolysis, admitted to hospital, extensive debridement, abdominal wall reconstruction, bilateral myofascial advancement flaps, and wound irrigation.
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Manufacturer Narrative
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Additional info: b5, b7, d8, g1, g3, h6 (patient codes, imf codes, device code).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 laparoscopic therapeutic treatment of an incisional hernia.It was reported that after the implant, the patient experienced fistula, mesh failure, incarceration of hernia, infection, recurrence, sinus tract, abscess, mesh migration, mesh was invaginated into the abdominal wall and herniated into defect, adhesions, cellulitis, inflammation, purulent material, erosion through fascia, fibrotic tissue, lack of incorporation, pain, exposed and unincorporated mesh, and chronic draining abdominal wound.Post-operative patient treatment included ct scan, medication, incision and drainage of abscess, use of jp and blake drain, revision surgery, excision of sinus tract, wound exploration/debridement, wound vac, removal of mesh, hernia repair with sutures and mesh, abdominal wall reconstruction, adhesiolysis, admitted to hospital, extensive debridement, abdominal wall reconstruction, bilateral myofascial advancement flaps, and wound irrigation.
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