|
Model Number SPM35 |
Device Problems
Loss of or Failure to Bond (1068); Degraded (1153); Material Erosion (1214); Migration or Expulsion of Device (1395); Product Quality Problem (1506); Detachment of Device or Device Component (2907); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
|
Patient Problems
Erosion (1750); Emotional Changes (1831); Foreign Body Reaction (1868); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Scarring (2061); Increased Sensitivity (2065); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Fibrosis (3167); No Code Available (3191); Increased Sensitivity (4538); Nodule (4551); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
|
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.After a procedure where this device was implanted, the patient experienced pain, bowel obstruction, and recurrence of hernia.Treatment included surgical revision and removal of the mesh.
|
|
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.
|
|
Manufacturer Narrative
|
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 an inguinal hernia.After treatment, the patient experienced nerve damage, infected mesh, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture.Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
|
|
Event Description
|
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an inguinal hernia.After treatment, the patient experienced surgical revision, removal surgery, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture.Post-operative patient treatment included additional surgery.
|
|
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 an inguinal hernia.After treatment, the patient experienced defective device, mental and physical pain, injury, disability, loss of enjoyment of life, nerve damage, infected mesh, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue, mesh entrapped in nerves, wadded up mesh, mesh broke loose, and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture.Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Manufacturer Narrative
|
This information was received as a part of an extensive mesh litigation submission to medtronic.The fda was notified of this large complaint receipt.Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target.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 an inguinal hernia.After treatment, the patient experienced nerve damage, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture.Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
|
|
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 an inguinal hernia.After treatment, the patient experienced inflammation, scarification, mesh encapsulation, lack of adequate ingrowth, fibrosis, giant cell reaction, defective device, mental and physical pain, injury, disability, loss of enjoyment of life, nerve damage, infected mesh, pain, bowel obstruction, recurrence, painful, tender, hard lump on right, extreme sensitivity and pain to right testicle and scrotum, scar tissue, mesh entrapped in nerves, wadded up mesh, mesh broke loose, and mesh was noted as gnarled, knotted, hard, red, fibrotic, and dislocated with fragments of prolene suture.Post-operative patient treatment included surgical revision, removal surgery, and additional surgery.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|