COLGATE SENSITIVE PRO-RELIEF DAILY USE PASTE
Received Oct 21, 2013 · Event occurred Jan 1, 2013
Report 1000117969-2013-00011 · MDR key 3429936
Device
Generic name
Tothpaste
Manufacturer
Colgae Palmolive Industrial Ltda.Product problems
- Patient-Device Incompatibility
Patient
23 YR
- Erosion
- Swelling
Narrative
Description of Event or Problem
INITIAL INFO WAS RECEIVED ON (B)(6) 2013 FROM A CONSUMER. A (B)(6) YEAR OLD MALE CONSUMER USED COLGATE SENSITIVE PRO-RELIEF DAILY USE PASTE TOOTHPASTE AND DEVELOPED TOOTH EROSION AND MOUTH SWELLING. HE BEGAN USING THE TOOTHPASTE THREE TIMES A DAY, FOUR MONTHS PRIOR TO THIS REPORT ON AN UNSPECIFIED DATE IN (B)(6) 2013 (DOSAGE UNK). SUBSEQUENTLY, ON AN UNSPECIFIED DATE IN 2013, HE EXPERIENCED THE EVENTS. THE TOOTHPASTE WAS DISCONTINUED ON AN UNSPECIFIED DATE IN 2013 AND THEN REINTRODUCED ON AN UNK DATE IN 2013 AND THE CONSUMER EXPERIENCED THE SAME EVENTS. A DENTIST WAS CONSULTED AND RECOMMENDED HE STOP USING THE TOOTHPASTE AS "HIS TEETH DIDN'T ADAPT WITH THE PRODUCT". TREATMENT INCLUDED DICLOFENAC, PARACETAMOL, LIDOCAINE AND CEPHALEXIN AS WELL AS A RECOMMENDED TOOTH EXTRACTION. AT THE TIME OF THIS REPORT, THE CONSUMER HAD DISCONTINUED THE TOOTHPASTE ON AN UNSPECIFIED DATE IN 2013 AND THE EVENTS WERE ONGOING. THIS CASE IS REFERENCED AS (B)(4).