InjuryKCZ

AMOENA

Received Oct 24, 2000 · Event occurred Jan 11, 2000

Report MW1020298 · MDR key 302753

Device

Generic name

Self-adhesive External

Manufacturer

Coloplast

Model number

880-8R

Catalog number

STYLE 061

Lot number

Product problems

Reaction

Patient

65 YR

Cellulitis
Rash
Sepsis
Septic Shock
Chills
Therapy/non-surgical treatment, additional
Hospitalization required

Narrative

Description of Event or Problem

RPTR STARTED HAVING CHILLS. WENT TO BED AND WOKE UP FEELING TERRIBLE. CHILD CAME AT 3 AND NOTICED RPTR HAD A BAD RED RASH ON CHEST WHERE BREAST WAS REMOVED. CALLED THE DR AND IT TOOK UP TO ABOUT AN HR TO GET THERE. THE NURSE MET RPTR AND SENT RPTR DIRECTLY TO ER. RPTR WAS ADMITTED TO HOSP AND WAS DIAGNOSED WITH CELLULITIS. THIS CAUSED RPTR TO GO INTO SEPTIC SHOCK. RPTR THINKS THE AMOENA PROSTHESIS CAUSED PROBLEM.