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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; PACK, HOT OR COLD, DISPOSABLE
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MEDLINE INDUSTRIES, INC.; PACK, HOT OR COLD, DISPOSABLE Back to Search Results
Device Problems Break (1069); Leak/Splash (1354)
Patient Problems Injury (2348); Chemical Exposure (2570)
Event Date 10/09/2019
Event Type  malfunction  
Event Description
Patient's grandmother asked for a few ice packs for her injured/back/neck.Nurse brought medline brand ice packs into room.Medline ice pack needed to be activated in order to make cold.Nurse and then patient's father each took ice pack to activate for the grandmother.Grandmother placed one ice pack on her neck and felt wetness, this is when we noticed both ice packs were broken open and milky fluid was leaking out packs.Fluid leaked all over grandmother's back and neck.Fluid also got on nurse's hands.Third ice pack then attempted to activate same problem noted and ice pack punctured somehow and fluid leaking out.Medline called to notify and were only concerned if fluid was ingested but suggested just washing skin well.Ice packs removed from our shelf in the meantime with same lot number.
 
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Type of Device
PACK, HOT OR COLD, DISPOSABLE
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
MDR Report Key9347017
MDR Text Key167152623
Report Number9347017
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 Other Health Care Professional
Type of Report Initial
Report Date 11/08/2019
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 Lay User/Patient
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2019
Event Location Hospital
Date Report to Manufacturer11/20/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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