3M ACE REUSABLE COLD COMPRESS
Received Sep 4, 2013 · Event occurred Jun 25, 2013
Report 2110898-2013-00045 · MDR key 3348843
Device
Generic name
890.5700
Manufacturer
3m Consumer Health CareModel number
207517Catalog number
207517
Lot number
UNK
Product problems
- Leak/Splash
Patient
UNK
- Skin Discoloration
- Skin Inflammation
Narrative
Description of Event or Problem
CUSTOMER REPORTS SHE USED ACE LARGE REUSABLE COLD COMPRESS ON THE BACK AND SIDE OF HER KNEE OVER THE COURSE OF APPROXIMATELY TWO WEEKS. CUSTOMER STATED, "THE AREA WAS REDDISH AND SWOLLEN" AND THEN SHE NOTICED THE COMPRESS WAS LEAKING WHEN SHE USED IT ON THE TOP PART OF HER KNEE APPROXIMATELY FOUR DAYS AGO. SHE WASHED HER LEG AND NOTICED THE REDNESS WAS MORE APPARENT. THEN PUT ALOE ON IT. CUSTOMER STATED, "I HAD THE FEELING OF "MY SKIN CRAWLING". HER SKIN IS ALSO A DARKER COLOR, DIFFERENT THAN THE REST OF HER SKIN. THE SWELLING IS GONE, BUT THERE ARE THREE AREAS OF DISCOLORATION AROUND THE MID-SECTION OF HER LEG. SHE HAS TAKEN BENADRYL. THE AREA DOES NOT ITCH, BUT WHEN SHE STOPS TAKING BENADRYL STILL HAS THAT "SKIN CRAWLING" FEELING. THE REDNESS IS BEGINNING TO FADE A LITTLE BIT, BUT STILL THERE. TREATED BY DERMATOLOGIST WITH HYDROQUINONE 4 PERCENT.