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Model Number PCO2520X |
Device Problems
Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Purulent Discharge (1812); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Seroma (2069); Hernia (2240); Impaired Healing (2378); Ascites (2596); Abdominal Distention (2601); 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 product: securestrap (product id: strap12, lot no: jck569).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 the implant, the patient experienced adhesions, mesh free floating, recurrence, scarring, seroma, infection, open wound, necrosis, pain, and fluid collection.Post-operative patient treatment included mesh dissected away from the peritoneal later/ resutured to the fascia, revision surgery, incision/ drainage of seroma/fluid collection, hernia repair with new mesh, excision of mesh, and debridement of necrotic granulated tissue.
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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 the implant, the patient experienced inflammation, dislodged mesh, mesh failure, hole in abdomen, adhesions, mesh free floating, recurrence, scarring, seroma, infection, open wound, necrosis, pain, and fluid collection.Post-operative patient treatment included mesh revision, medication, wound care, use of jp drain, mesh dissected away from the peritoneal later/resutured to the fascia, revision surgery, incision/drainage of seroma/fluid collection, hernia repair with new mesh, excision of mesh, and debridement of necrotic granulated tissue.Concomitant device: securestrap (product id: strap12, lot no: jck569).
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Manufacturer Narrative
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Additional info: b5, b7, g1, g3, h6 (added patient codes and device codes).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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Additional information: b5, b6, b7, h6 (added patient codes) ime 2402: fibrinous material, tract.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 the implant, the patient experienced inflammation, dislodged mesh, mesh failure, hole in abdomen, adhesions, mesh free floating, recurrence, scarring, seroma, infection, open wound, necrosis, pain, fibrinous material, fibrinopurulent material, necrotic adipose tissue, tract, granulation tissue, bulging, and fluid collection.Post-operative patient treatment included mesh revision, medication, wound care, use of jp drain, mesh dissected away from the peritoneal later/resutured to the fascia, revision surgery, incision/drainage of seroma/fluid collection with curettage of granulation tissue, hernia repair with new mesh, excision of mesh, and debridement of necrotic granulated tissue.Concomitant device: securestrap (product id: strap12, lot no: jck569).
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Search Alerts/Recalls
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