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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. INFANT HEEL WARMERS; INFANT HEEL WARMER (CHEMICAL HEAT PACK)
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MEDLINE INDUSTRIES, INC. INFANT HEEL WARMERS; INFANT HEEL WARMER (CHEMICAL HEAT PACK) Back to Search Results
Model Number MDS138007
Device Problem Temperature Problem (3022)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2023
Event Type  malfunction  
Event Description
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.
 
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Brand Name
INFANT HEEL WARMERS
Type of Device
INFANT HEEL WARMER (CHEMICAL HEAT PACK)
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key17245787
MDR Text Key318282471
Report Number17245787
Device Sequence Number1
Product Code MPO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/22/2023
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 Model NumberMDS138007
Device Lot NumberVN22124A18
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/22/2023
Event Location Hospital
Date Report to Manufacturer07/03/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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