|
Model Number PCO6VP |
Device Problems
Loss of or Failure to Bond (1068); Migration or Expulsion of Device (1395); Material Perforation (2205); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Adhesion(s) (1695); Inflammation (1932); Nerve Damage (1979); Pain (1994); Swelling (2091); Hernia (2240); Injury (2348); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
|
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
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, the patient experienced severe pain, swelling, omental adhesions, recurrence, eventration of the mesh, mesh pulled away from the repair, lack of incorporation, and partial mesh excision.
|
|
Event Description
|
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 the implant, the patient experienced severe pain, swelling, omental adhesions, recurrence, eventration of mesh, mesh pulled away from the repair and lack of incorporation.Post-operative patient treatment included partial mesh excision.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
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 the implant, the patient experienced inflammation, nerve damage, severe pain, swelling, omental adhesions, recurrence, eventration of mesh, mesh pulled away from the repair and lack of incorporation.Post-operative patient treatment included partial mesh excision, mesh removal, medication, hernia repair with mesh.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|