MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC ACCU-THERM HOT PACK; HOTPACK INSTANT

Catalog Number MDS138005

Device Problems Device Markings/Labelling Problem (2911); Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 12/06/2015

Event Type  malfunction  

Event Description

Hotpack was covered with a t-shirt and placed on patient.Patient sustained first degree burns with blisters.The instructions for use on the label of this device are unclear.The instructions indicate to cover the device with a cloth.Instructions also indicate not to place the device on an infant, but do not provide an age range or a lower age limit for device use.When activated and shaken, the device does not distribute heat evenly.There are areas of increased heat in the device, especially in the corners.A new pack was activated and a section of it reached 178 degrees.This facility is concerned for the potential this device has to burn a child.All of this product was removed from use and will be returned to the manufacturer.The facility is replacing this device with a different product.

Event Description

Hotpack was covered with a t-shirt and placed on patient.Patient sustained second degree burns with blisters.The instructions for use on the label of this device are unclear.The instructions indicate to cover the device with a cloth.Instructions also indicate not to place the device on an infant, but do not provide an age range or a lower age limit for device use.When activated and shaken, the device does not distribute heat evenly.There are areas of increased heat in the device, especially in the corners.A new pack was activated and a section of it reached 178 degrees.This facility is concerned for the potential this device has to burn a child.All of this product was removed from use and will be returned to the manufacturer.The facility is replacing this device with a different product.

• Brand Name: ACCU-THERM HOT PACK
• Type of Device: HOTPACK INSTANT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline place; mundelein IL 60060
• MDR Report Key: 5339952
• MDR Text Key: 34897627
• Report Number: 5339952
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MDS138005
• Device Lot Number: CN15282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2015
• 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR