InjuryOOD
GALAFLEX
Received Apr 12, 2024 · Event occurred Mar 10, 2024
Report MW5153837 · MDR key 19104962
Device
Generic name
Surgical Film
Manufacturer
Tepha, IncorporatedPatient
Female
- Bacterial Infection
- Bacterial Infection
Narrative
Description of Event or Problem
GALAFLEX ALMOST KILLED ME. TWICE. I NEVER KNEW IT WAS NOT APPROVED BY THE FDA.I HAD TO HAVE TWO SURGERIES AND CONTRACTED CLOSTRIDIOIDES DIFFICILE FROM THE AMOUNT OF THE ANTIBIOTICS.