InjuryEBH
HYDROSIL
Received Jan 20, 2006 · Event occurred Feb 15, 2005
Report 2515379-2005-00540 · MDR key 666024
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Irritation
- Rash
- Soreness
- Burning Sensation
- Surgical procedure
- Reaction
- Treatment with medication(s)
Narrative
Description of Event or Problem
A PT CLAIMS TO HAVE DEVELOPED A RASH, PIMPLES, BURNING SENSATIONS, AND LATER SORES/LESIONS ON THE FACE IN THE AREA WHERE HYDROSIL XT CONTACTED THE SKIN DURING AN IMPRESSION PROCEDURE. THE PT NOTED THE SYMPTOMS BEGAN TO DEVELOP A SHORT TIME AFTER THE PROCEDURE AND HAD BEEN PRESENT FOR APPROX TEN MONTHS AT THE TIME THE EVENT WAS REPORTED. TWO DOCTORS WERE CONSULTED AND THE PT WAS ADMINISTERED ANTIBIOTICS, STEROIDS, AND A BURN CREAM TO TREAT THE SYMPTOMS. ADDITIONALLY, A BIOPSY WAS PERFORMED ON THE AREA AND THE SYMPTOMS CLASSIFIED AS A "CHEMICAL/SUN IRRITATION REACTION."