Model Number PCOPM15 |
Device Problems
Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
|
Patient Problems
Abdominal Pain (1685); Adhesion(s) (1695); Internal Organ Perforation (1987); Renal Failure (2041); Seroma (2069); Hernia (2240); Peritonitis (2252); Injury (2348); Ascites (2596); No Code Available (3191)
|
Event Type
Injury
|
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 incisional hernia.
It was reported that after implant, the patient experienced extensive adhesions, recurrence, bowel incarceration, seroma and perforation in the conduit with urinoma.
Post-operative patient treatment included lysis of adhesions, explant of previous mesh and repair of hernia with new mesh.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
The patient's attorney alleged a deficiency against the device resulting in an unspecified adverse outcome.
Product was used for therapeutic treatment.
The patient underwent a herniorrhaphy incisional laparoscopic ro.
He had revision surgery 2 days post-surgery.
The patient experienced surgical revision, extensive adhesions, perforation in the conduit with urinoma.
|
|
Search Alerts/Recalls
|