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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PACK,HOT,INSTANT,LRG,6X9"; PACK, HOT OR COLD, DISPOSABLE
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MEDLINE INDUSTRIES, INC. PACK,HOT,INSTANT,LRG,6X9"; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Model Number MDS139009
Patient Problem Chemical Exposure (2570)
Event Date 11/20/2023
Event Type  malfunction  
Event Description
Cna (certified nursing assistant) came to writer to let writer know that a heat pack had just exploded on her while she was activating it, contents did get on her left arm and wrist area.Cna did fill out a staff accident report.Cna reported that she was correctly activating heat pack where the arrows on the sides were while holding it upright using 2 fingers.The contents of the heat pack came out of the upper side of the bag.Of note, the heat pack was discarded, and garbage was removed prior to being able to save the heat pack.Numbers listed below are from current stock in drawer, assuming the damaged heat pack numbers match what's left in the drawer.
 
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Brand Name
PACK,HOT,INSTANT,LRG,6X9"
Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key18236919
MDR Text Key329363915
Report Number18236919
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/20/2023
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 Operator Other
Device Model NumberMDS139009
Device Catalogue NumberMDS139009
Device Lot NumberCN23146-3490
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/20/2023
Event Location Hospital
Date Report to Manufacturer11/30/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/30/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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