SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO20 |
Device Problems
Degraded (1153); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Corneal Pannus (1447); Abdominal Pain (1685); Adhesion(s) (1695); Anemia (1706); Asthma (1726); Bacterial Infection (1735); Erosion (1750); Cellulitis (1768); Granuloma (1876); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Urinary Tract Infection (2120); Burning Sensation (2146); Hernia (2240); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); 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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Concomitant: pco9 parietex comp 3d py 9 cir no thrx1 (lot# pkh00365); abstack20 5 mm sgl use abs dev 20 tacks (lot# unknown).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 a ventral hernia.It was reported that after implant, the patient experienced infection, seroma, abdominal wall fluid, abdominal wall cellulitis, omentum adhesions to mesh, hernia recurrence, obstruction, suture granuloma, chronic pain, open wound, (b)(6), pseudomonas aeruginosa, fluid collection, abdominal pain, asthma exacerbation, felt abdomen "ripping open", diastasis recti, pannus, burning/stretching sensation, scarring, attenuation, granuloma, anemia, uti, necrotic skin, mesh traveling laterally, and granulating mesh.Post-operative patient treatment included seroma fluid drainage, adhesion removal, mesh removal, hernia repair surgery with implant of new mesh, abdominal debridement, aspiration of fluid collection, admission to hospital, complex abdominal wall reconstruction, component separation of the abdominal wall with bilateral ramirez external oblique anterior releases and myofascial advancement, negative pressure wound dressing, removal of tacks/sutures, primary closure of fascia, medication, debridement of necrotic skin/subcutaneous tissue, and wound vac.
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Manufacturer Narrative
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Additional info: b5, g1 (manufacturer name, mfr contact first name, last name, street 1, mfr city, region, country code, postal code, email, phone number), g3, h6.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 a ventral hernia.It was reported that after implant, the patient experienced infection, seroma, abdominal wall fluid, abdominal wall cellulitis, omentum adhesions to mesh, hernia recurrence, obstruction, suture granuloma, chronic pain, open wound, mrsa, pseudomonas aeruginosa, fluid collection, abdominal pain, asthma exacerbation, felt abdomen "ripping open", diastasis recti, pannus, burning/stretching sensation, scarring, attenuation, granuloma, anemia, uti, necrotic skin, mesh traveling laterally, mesh erosion and granulating mesh.Post-operative patient treatment included seroma fluid drainage, adhesion removal, mesh removal, hernia repair surgery with implant of new mesh, abdominal debridement, aspiration of fluid collection, admission to hospital, complex abdominal wall reconstruction, component separation of the abdominal wall with bilateral ramirez external oblique anterior releases and myofascial advancement, negative pressure wound dressing, removal of tacks/sutures, primary closure of fascia, medication, debridement of necrotic skin/subcutaneous tissue, and wound vac.
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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 a ventral hernia.It was reported that after implant, the patient experienced infection, inflammation, cellulitis, abdominal pain, seroma, abdominal wall fluid, abdominal wall cellulitis, omentum adhesions to mesh, hernia recurrence, obstruction, suture granuloma, chronic pain, open wound, mrsa, pseudomonas aeruginosa, fluid collection, abdominal pain, asthma exacerbation, felt abdomen "ripping open", diastasis recti, pannus, burning/stretching sensation, scarring, attenuation, granuloma, anemia, uti, necrotic skin, mesh traveling laterally, mesh erosion and granulating mesh.Post-operative patient treatment included seroma fluid drainage, adhesion removal, mesh removal, hernia repair surgery with implant of new mesh, abdominal debridement, aspiration of fluid collection, admission to hospital, complex abdominal wall reconstruction, component separation of the abdominal wall with bilateral ramirez external oblique anterior releases and myofascial advancement, negative pressure wound dressing, removal of tacks/sutures, primary closure of fascia, medication, debridement of necrotic skin/subcutaneous tissue, ct-scan, and wound vac.Relevant tests/laboratory data: 11 jun 2019: op note stated ct scan of abdomen/pelvis demonstrated abdominal wall changes from previous repairs, epigastric ventral recurrent incisional hernia, one at umbilicus 11 jun 2019: op note stated note from primary care provider on 04 apr 2019 stated history of mrsa 20 jun 2019: deep wound culture showed 2+ pseudomonas aeruginosa.
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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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