|
Model Number TET1309 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Abdominal Pain (1685); Nausea (1970); Pain (1994); Vomiting (2144); Hernia (2240); Obstruction/Occlusion (2422); Abdominal Distention (2601); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
Event Type
Injury
|
Manufacturer Narrative
|
Concomitant medical devices: ppm1510x3 parietene macro pp 15x10cmx3 (lot# srk0428x); abstack30 abs fixation device 30 tacks (lot#n8e0459mx).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 laparoscopic therapeutic treatment of bilateral inguinal hernias and a supraumbilical ventral hernia.It was reported that after implant, the patient experienced nausea, vomiting, pain, small bowel obstruction, fibrofatty tissue with mild fibrosis, abdominal pain, coughing, bulge, mesh pulled away, and recurrence.Post-operative patient treatment included revision surgery, hernia repair with new mesh, bilateral component separation, sac excised, and mesh removal.
|
|
Manufacturer Narrative
|
Additional info: a4, b5, b7, h6 (patient codes, imf code, ime e2402 updated to: "fibrofatty tissue"), 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.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for laparoscopic therapeutic treatment of bilateral inguinal hernias and a supraumbilical ventral hernia.It was reported that after implant, the patient experienced inflammation, adhesions, nausea, vomiting, pain, small bowel obstruction, fibrofatty tissue with mild fibrosis, abdominal pain, coughing, bulge, mesh pulled away, and recurrence.Post-operative patient treatment included ct scan, revision surgery, hernia repair with new mesh,bilateral component separation, sac excised, and mesh removal.
|
|
Search Alerts/Recalls
|
|
|