INFANT HEEL WARMER,SQUEEZE, 4X4IN
Received Aug 26, 2022 · Event occurred Jul 12, 2022
Report 1423537-2022-00831 · MDR key 15301337
Device
Generic name
Infant Heel Warmer (chemical Heat Pack)
Manufacturer
Cardinal Health 200, LlcModel number
11460-010TCatalog number
11460-010T
Lot number
V2E068D
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
REVIEW OF THE DEVICE HISTORY REPORT WAS COMPLETED ON THE REPORTED LOT NUMBER, V2E068. THE LOT WAS FOUND TO HAVE BEEN MANUFACTURED ON 5/05/22 AND RELEASED TO PREDETERMINED SPECIFICATIONS. NO ANOMALIES WERE FOUND DURING REVIEW OF THE RECORDS. NO PHYSICAL SAMPLES WERE RETURNED DUE TO WHICH A ROOT CAUSE COULD NOT BE DETERMINED. SAMPLE PHOTOS WERE REVIEWED, BUT WE ARE STILL NOT ABLE TO DETERMINE A ROOT CAUSE BASED ON EVALUATION OF PHOTOS. CARDINAL HEALTH WILL CONTINUE TO MONITOR COMPLAINT TRENDS FOR THIS ISSUE.
Description of Event or Problem
CUSTOMER REPORTED ON MW0800040000-2022-8033 THAT WHEN ACTIVATING WARMER, THE PRODUCT BROKE OPEN AND CONTENTS CONTACTED PATIENT¿S SKIN. NO PATIENT DEMOGRAPHIC PROVIDED.