inforMED
InjuryIME

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

Model number

207517

Catalog 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.