SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC
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Model Number PCO2520 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
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Patient Problems
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Edema (1820); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Scarring (2061); Seroma (2069); Discharge (2225); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Ascites (2596); Abdominal Distention (2601); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)
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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, in (b)(6) 2012, the patient experienced abdominal wall fluid collection, seroma, as well as abscess and underwent ct guided aspiration but multiple attempts to place drain were unsuccessful due to mesh.Then in (b)(6) 2012, the patient experienced drainage of abdominal seroma but the mesh split with scalpel to release drainage of serous fluid so the mesh was reapproximated to fascia.Later that month, the patient underwent removal of infected mesh, wound infection, and abscess cavity.Treatment provided for these conditions included additional mesh implant in (b)(6) 2013.In (b)(6) 2014, the patient experienced extensive lysis of adhesions down from omentum to previous mesh, small fluid collection above the mesh, evacuation of postoperative hematoma, and abdominal pain.In (b)(6) 2016, the patient experienced revision of prior mesh, lysis of adhesions, bulge in abdominal wall under mesh, a small opening made in mesh and recurrent hernia repaired with new biologic mesh.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 incisional hernia.It was reported that after implant, the patient experienced abdominal wall fluid collection, seroma, drainage of serous fluid, scarring, abscess, adhesions, recurrence, wound infection, pain, tenderness, purulent fluid, bulge in abdominal wall under mesh, small opening made in mesh, abdominal pain and hematoma.This device was used was absorbable tacks.Post-operative patient treatment included ct guided aspiration with attempted drainage catheter placement, removal of infected mesh, extensive lysis of adhesions down from omentum to previous mesh, evacuation of postoperative hematoma, drainage of abdominal seroma but the mesh split with scalpel to release drainage of serous fluid so the mesh was reapproximated to fascia, revision of prior mesh and recurrent hernia repaired with new biologic mesh.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 abdominal wall fluid collection, seroma, abscess, adhesions, recurrence, wound infection, bulge in abdominal wall under mesh, small opening made in mesh, abdominal pain and hematoma.Post-operative patient treatment included ct guided aspiration with attempted drainage catheter placement, removal of infected mesh, extensive lysis of adhesions down from omentum to previous mesh, evacuation of postoperative hematoma, drainage of abdominal seroma but the mesh split with scalpel to release drainage of serous fluid so the mesh was reapproximated to fascia, revision of prior mesh and recurrent hernia repaired with new biologic mesh.
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Manufacturer Narrative
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This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 abdominal wall fluid collection, seroma, scarring, abscess, adhesions, recurrence, wound infection, purulent fluid, bulge in abdominal wall under mesh, small opening made in mesh, abdominal pain and hematoma.Post-operative patient treatment included ct guided aspiration with attempted drainage catheter placement, removal of infected mesh, extensive lysis of adhesions down from omentum to previous mesh, evacuation of postoperative hematoma, drainage of abdominal seroma but the mesh split with scalpel to release drainage of serous fluid so the mesh was reapproximated to fascia, revision of prior mesh and recurrent hernia repaired with new biologic mesh.
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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 laparoscopic therapeutic treatment of a ventral incisional hernia.It was reported that after implant, the patient experienced abdominal wall fluid collection, seroma, drainage of serous fluid, scarring, abscess, adhesions, recurrence, wound infection, pain, tenderness, purulent fluid, bulge in abdominal wall under mesh, small opening made in mesh, abdominal pain, inflammation, bleeding, depression, and hematoma.This device was used was absorbable tacks.Post-operative patient treatment included ct guided aspiration with attempted drainage catheter placement, removal of infected mesh, extensive lysis of adhesions down from omentum to previous mesh, evacuation of postoperative hematoma, drainage of abdominal seroma but the mesh split with scalpel to release drainage of serous fluid so the mesh was reapproximated to fascia, revision of prior mesh, hospitalization for 7 days, and recurrent hernia repaired with new biologic mesh.Relevant tests/laboratory data: (b)(6) 2012: op note- ct scan was unremarkable except for some fluid around the area of the hernia repair.(b)(6) 2016: op note- ct scans and egd confirmed recurrence of hiatal hernia.
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Search Alerts/Recalls
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