inforMED
MalfunctionMPO

MEDLINE DISC HEEL WARMER

Received May 23, 2022 · Event occurred Apr 12, 2022

Report MW5109864 · MDR key 14488516

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

MDS138009

Catalog number

MDS138009

Lot number

VN21349A14

Product problems

  • Fluid/Blood Leak

Patient

1 DA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

FROM RN INVOLVED: I DID NOT NOTICE ANY DAMAGE TO HEEL WARMER PRIOR TO ACTIVATION. HEEL WARMER WAS ACTIVATED BY BENDING THE METAL DISK ENCLOSE IN PACK. ONCE THE HEEL WARMER WAS ACTIVATED, I WAS SECURING IT TO THE INFANTS LEG/FOOT WHEN I NOTICED MOISTURE AND FOUND THAT THE HEEL WARMER WAS LEAKING THE WARMING CONTENTS FROM THE SEAMS. I REMOVED THE HEEL WARMER FROM THE INFANT AND THE BASSINET. I WIPED THE INFANT'S LEG/FOOT WITH A DRY BLANKET AND THEN WASH THE LEG/FOOT WITH A WET WASH CLOTH. (I WAS CONCERNED WITH EITHER A CHEMICAL BURN OR THERMAL BURN TO SKIN FROM THE HEEL WARMER CONTENTS) I EXAMINED THE LEG/FOOT FOR ANY TYPE OF BURN OR INJURY TO THE SITE. ALL SKIN LOOKED NORMAL AND NO INJURY WAS NOTED. FDA SAFETY REPORT ID# (B)(4).