KELO-COTE
Received Apr 12, 2013 · Event occurred Mar 9, 2013
Report MW5029766 · MDR key 3062780
Device
Generic name
Advanced Formula Scar Gel, 15 Gm
Lot number
435
Product problems
- Insufficient Device Problem Information
Patient
Not reported
- Bacterial Infection
- Purulent Discharge
- Erythema
- Pain
- Staphylococcus Aureus
- Discomfort
- Caustic/Chemical Burns
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
COMPLAINANT PURCHASED KELO-COTE 15G FROM (B)(4) ON (B)(6) 2013. COMPLAINANT USED THE PRODUCT TWO DAYS ON THE WEEK OF (B)(6) 2013. WHILE USING THE PRODUCT THOSE TWO DAYS, SHE NOTICED THE AREAS WHERE SHE RUBBED THE GEL WERE FEELING "RUBBERY", HARDENED, AND DRY. SHE USED THE PRODUCT ON HER CHEST AND LOWER STOMACH, BIKINI LINE AREA. ON (B)(6) 2013, SHE NOTICED THAT HER NAVEL WAS REALLY SORE AND STARTED TO OPEN. SHE DESCRIBED AS LOOKING LIKE A "BLOOD SHOT EYE." SHE WENT TO THE EMERGENCY ROOM THAT DAY AND THE DOCTOR INFORMED HER THAT SHE HAD BLISTERS WITH PUS INSIDE OF THEM AND RED STREAKS UNDER HER NAVEL WHICH INDICATE A STAPH INFECTION. THE DOCTOR PRESCRIBED HER MEDICATION AND HER NAVEL IS BACK TO NORMAL NOW. HOSPITAL NAME: (B)(6).