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Model Number PCO9X |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930); Nausea (1970); Pain (1994); Staphylococcus Aureus (2058); Vomiting (2144); Discharge (2225); Hernia (2240); Injury (2348); Impaired Healing (2378); Fluid Discharge (2686); 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 laparoscopic therapeutic treatment of an umbilical hernia.It was reported that after the implant, the patient experienced infection, adhesions, staphylococcus aureus, and chronic draining wound.Post-operative patient treatment included revision surgery, antibiotics, wound excised, and removal of infected mesh.
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Manufacturer Narrative
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Additional information: (weight in lbs).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 umbilical hernia.It was reported that after the implant, the patient experienced infection, adhesions, staphylococcus aureus, abscess, drains green pus, pain, nausea, vomiting, and chronic draining wound.Post-operative patient treatment included revision surgery, antibiotics, wound excised, and removal of infected mesh.
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Manufacturer Narrative
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Additional information: b5, b6, d8, e1 (facility name, street 1, city, region, postal code, g1 (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 an umbilical hernia.It was reported that after the implant, the patient experienced infection, hernia recurrence, adhesions, staphylococcus aureus, abscess, drains green pus, pain, nausea, vomiting, and chronic draining wound.Post-operative patient treatment included revision surgery, antibiotics, wound excised, and removal of infected mesh.
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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 an umbilical hernia.It was reported that after the implant, the patient experienced infection, hernia recurrence, adhesions, staphylococcus aureus, abscess, drains green pus, pain, nausea, vomiting, and chronic draining wound.Post-operative patient treatment included ct-scan, medication, revision surgery, antibiotics, wound excised, and removal of infected mesh.Concomitant device: unknown securestrap device relevant tests/laboratory data: (b)(6) 2018: op note- 3 days following previous umbilical hernia repair, patient developed staph (staphylococcus aureus) infection at that area.-ct scan abdomen/pelvis showed wound appearing to go down to mesh.On (b)(6) 2018: pathology report from umbilical are soft tissue excision noted area of microabscess formation, surgical mesh.
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Search Alerts/Recalls
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