inforMED
MalfunctionMPO

INFANT HEEL WARMERS

Received Jul 3, 2023 · Event occurred Feb 22, 2023

Report 17245787 · MDR key 17245787

Device

Generic name

Infant Heel Warmer (chemical Heat Pack)

Model number

MDS138007

Lot number

VN22124A18

Product problems

  • Temperature Problem

Patient

Unknown

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

Narrative

Description of Event or Problem

TWO MEDLINE INFANT HEEL WARMERS NOTED TO BE COLD RATHER THAN WARM WHEN CRACKED. LOT #VN22124A18. SAVED AND GIVEN TO APSM. MANUFACTURER RESPONSE FOR INFANT HEEL WARMERS, INFANT HEEL WARMERS (PER SITE REPORTER) [REDACTED NAME] RETRIEVING THE ITEM ON [REDACTED DATE]. HE WILL ENTER PRODUCT IDENTIFIERS IF AVAILABLE. E-MAILED [REDACTED NAME] TO REPORT INCIDENT AND OFFER SAMPLES FOR ANALYSIS. [REDACTED DATE]- [REDACTED NAME] RETRIEVED THE SAMPLES FROM [REDACTED NAME] AND HAS FILED A COMPLAINT WITH MEDLINE. [REDACTED DATE]- [REDACTED NAME] EMAILED MEDLINE REQUESTING THE RMA. [REDACTED DATE]- EMAIL REMINDER SENT TO MEDLINE. [REDACTED DATE]- RMA AND MAILER LABEL RECEIVED; MEDLINE REF# 200546392-30. [REDACTED DATE]- SAMPLE SHIPPED FEDEX.