SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2015OS |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Wound Dehiscence (1154); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Ecchymosis (1818); Edema (1820); Emotional Changes (1831); Erythema (1840); Fatigue (1849); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Necrosis (1971); Pain (1994); Staphylococcus Aureus (2058); Scar Tissue (2060); Scarring (2061); Sepsis (2067); Seroma (2069); Vomiting (2144); Chills (2191); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Ascites (2596); Blood Loss (2597); Fluid Discharge (2686); No Code Available (3191); Nodule (4551); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 therapeutic treatment of a hernia.It was reported that after implant, the patient experienced chronic pain, massive infection, an abscess, and non-incorporation of the mesh.Treatment required includes surgical removal of the mesh eight years after implant.
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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 incisional hernia.It was reported that after implant, the patient experienced chronic pain, massive infection, abscess, open wound, dense adhesions and non-incorporation of the mesh.Treatment required includes surgical removal of the mesh eight years after implant, wound vac and additional implant.
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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 incisional hernia.It was reported that after implant, the patient experienced chronic pain, massive infection, abscess, open wound, dense adhesions, non-incorporation of the mesh, morganella morganii, staphylococcus aureus, acinetobacter, e coli, pseudomonas, beta hemolytic strep group c and b, splenomegaly, hepatosplenomegaly, fluid density, seroma, hematoma, (b)(6), wound dehiscence, non-healing incision, ecchymosis in the center of wound, redness around incision, bleeding of bright red blood around staples, large amount of serous/yellow tinged fluid, musty odor, necrosis, serosanguinous exudate with mild odor, scarring, severe sepsis with hospitalization in icu, cellulitis, fevers, fatigue, chills, abdominal lump, sclerosis, abdominal pain, baseballsized mass to left upper quadrant with hospitalization, recurrent abdominal wall abscess with infected mesh, skin and tissue edematous with scarring and induration, floating piece of mesh with attached staples, nausea and vomiting.Post-operative patient treatment included multiple surgical procedures for abdominal wall wound, surgical removal of the mesh, wound vac and additional implant.
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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 incisional hernia.It was reported that after implant, the patient experienced chronic pain, massive infection, abscess, open wound, dense adhesions, non-incorporation of the mesh, morganella morganii, staphylococcus aureus, acinetobacter, e coli, pseudomonas, beta hemolytic strep group c and b, splenomegaly, hepatosplenomegaly, fluid density, seroma, hematoma, (b)(6), wound dehiscence, non-healing incision, ecchymosis in the center of wound, redness around incision, bleeding of bright red blood around staples, large amount of serous/yellow tinged fluid, musty odor, necrosis, serosanguinous exudate with mild odor, scarring, severe sepsis, cellulitis, fevers, fatigue, chills, abdominal lump, sclerosis, abdominal pain, baseball sized mass to left upper quadrant, recurrent abdominal wall abscess with infected mesh, skin and tissue edematous with scarring, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and induration, floating piece of mesh with attached staples, nausea and vomiting.Post-operative patient treatment included multiple surgical procedures for abdominal wall wound, surgical removal of the mesh, wound vac, hospitalization, icu, and additional implant.
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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.The product was used for therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced hernia recurrence, drainage, fluid collection, chronic pain, massive infection, abscess, open wound, dense adhesions, non-incorporation of the mesh, morganella morganii, staphylococcus aureus,acinetobacter, e coli, pseudomonas, beta hemolytic strep group c and b, splenomegaly, hepatosplenomegaly, fluid density, seroma, hematoma, methicillin sensitive streptococcus aureus, wound dehiscence, non-healing incision, ecchymosis in the center of wound, redness around incision, bleeding of bright red blood around staples, large amount of serous/yellow tinged fluid, musty odor, necrosis, serosanguinous exudate with mild odor, scarring, severe sepsis, cellulitis, fevers, fatigue, chills, abdominal lump, sclerosis, abdominal pain, baseball sized mass to left upper quadrant, recurrent abdominal wall abscess with infected mesh, skin and tissue edematous with scarring, mental pain, disability, impairment, loss of enjoyment of life, defective mesh, and induration, floating piece of mesh with attached staples, nausea and vomiting.Post-operative patient treatment included ct scan, urogram, mri, abscessogram, debridement, revision surgery, multiple surgical procedures for abdominal wall wound, surgical removal of the mesh, wound vac, hospitalization, icu, and additional implant.
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Search Alerts/Recalls
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