|
Model Number 1DLMC04 |
Device Problem
Insufficient Information (3190)
|
Patient Problems
Erosion (1750); Unspecified Infection (1930); Inflammation (1932); Obstruction/Occlusion (2422)
|
Event Date 09/08/2021 |
Event Type
Injury
|
Event Description
|
It was reported to gore that the patient underwent laparoscopic ventral incisional hernia repair on (b)(6) 2008 whereby a gore® dualmesh® biomaterial was implanted.
The complaint alleges that on (b)(6) 2019, (b)(6) 2020, and (b)(6) 2020, additional procedures occurred whereby the gore device was explanted.
It was reported the patient alleges the following injuries: mesh failure and erosion, infection, inflammation, adhesions and bowel obstruction, producing chronic pain.
Additional event specific information was not provided.
|
|
Manufacturer Narrative
|
It should be noted that the gore® dualmesh® biomaterial instructions for use addresses the following adverse reactions among others: ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
" the gore® dualmesh® biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.
If an infection develops, it should be treated aggressively.
An unresolved infection may require removal of the material.
".
|
|
Search Alerts/Recalls
|
|
|