• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARDINAL HEALTH 200, LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK) Back to Search Results
Model Number 11460-010T
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2022
Event Type  malfunction  
Event Description
Customer has reported that the heel warmer busted open before placing it on the patient.No injury, the heel warmer was thrown in the trash without incident.
 
Manufacturer Narrative
Supplemental report is being filed since data for section h10 was missing in the original submission.Device history record review was completed on the reported lot number, v2b110.The lot was found to have been manufactured on february 10, 2022 and released to predetermined specifications.No anomalies were found during review of the records.No samples were returned for evaluation therefore a root cause could not be determined.Cardinal health will continue to monitor complaint trends for this issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFANT HEEL WARMER,SQUEEZE, 4X4IN
Type of Device
INFANT HEEL WARMER (CHEMICAL HEAT PACK)
Manufacturer (Section D)
CARDINAL HEALTH 200, LLC
3651 birchwood drive
waukegan IL 60085
Manufacturer (Section G)
MO016 MO-MOBERLY
808 w highway 24
moberly MO 65270
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key14538672
MDR Text Key299562289
Report Number1423537-2022-00775
Device Sequence Number1
Product Code MPO
UDI-Device Identifier10630140017391
UDI-Public10630140017391
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number11460-010T
Device Catalogue Number11460-010T
Device Lot NumberV2B110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/12/2022
Initial Date FDA Received05/28/2022
Supplement Dates Manufacturer Received05/12/2022
Supplement Dates FDA Received06/22/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/10/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age26 YR
Patient SexFemale
-
-