|
Model Number PPM1510X3 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Failure of Implant (1924); Unspecified Infection (1930); 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 left inguinal hernia.It was reported that after implant, the patient experienced sinus tract, failure of mesh, and infection.Post-operative patient treatment included partial mesh removal surgery.
|
|
Search Alerts/Recalls
|
|
|