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Model Number UNKNOWN PARIETEX PRODUCT |
Device Problems
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
Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Seroma (2069); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Bowel Perforation (2668); 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 laparoscopic therapeutic treatment of a ventral hernia.It was reported that after the implant, the patient experienced pain and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, and daily antibiotics.
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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 the implant, the patient experienced pain, abscess, dense adhesions, open wound, abdominal pain, small bowel perforation, discharge, mesh dehisced, seroma, infection, sinus tract, mesh migration, unincorporated mesh, free air, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, wound vac, small bowel resection with primary anastamosis, admission to hospital, lysis of adhesions, component separation, washout, wound vac dressing, removal of sutures/tacks, mesh removal, and daily antibiotics.
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Manufacturer Narrative
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Additional information: patient code: c64343(sinus tract, free air).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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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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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 the implant, the patient experienced pain, abscess, dense adhesions, open wound, abdominal pain, small bowel perforation, discharge, mesh dehisced, seroma, infection, sinus tract, mesh migration, unincorporated mesh, free air, emotional distress, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, wound vac, small bowel resection with primary anastamosis, admission to hospital, lysis of adhesions, component separation, washout, wound vac dressing, removal of sutures/tacks, mesh removal, cat scan, and daily antibiotics.
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Search Alerts/Recalls
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