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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH INSTANT HOT PACK; HEAT PACK
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CARDINAL HEALTH INSTANT HOT PACK; HEAT PACK Back to Search Results
Catalog Number 11450-040
Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Caustic/Chemical Burns (2549)
Event Date 01/23/2018
Event Type  malfunction  
Event Description
The nurse coordinator completed this report: patient was squeezing heat pack as directed heat pack leaked all over patient's hands.This occurred on 3 separate packs.Small slit to bottom of pack noted.There was slight burn to bilateral hands.Per site reporter: i spoke to customer service.They are going to send me a shipping label to send the devices back.They will also follow up with me on what they find.I also told them that we have had other issues in the hospital and i am waiting for more information.I will send more reports if i get more info.
 
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Brand Name
INSTANT HOT PACK
Type of Device
HEAT PACK
Manufacturer (Section D)
CARDINAL HEALTH
7000 cardinal place
dublin OH 43017
MDR Report Key7285417
MDR Text Key100571474
Report Number7285417
Device Sequence Number1
Product Code IMD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/25/2018,02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number11450-040
Device Lot NumberV7L291, V7L066
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/25/2018
Event Location Hospital
Date Report to Manufacturer01/25/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
Patient Outcome(s) Other;
Patient Age37 YR
Patient Weight58
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