MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; PACK,HOT,INSTANT,NON-INSULATED,6"X10"

Catalog Number MDS138005

Device Problem Material Rupture (1546)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 02/03/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the hot pack burst during activation.Reportedly, the hot pack was "twisted" by the user in order to activate it.The hot pack contents made contact with the user's skin and she experienced redness and a burning sensation below her left ear, on an unidentified cheek, and under her left eye.The staff member immediately rinsed her skin with water and "applied a wet, cool cloth to the affected areas." reportedly, she went to a local urgent care center where she was diagnosed with "second-degree" burns, was given a tetanus injection, and was provided with bacitracin for application on the affected areas.There was no reported impact or adverse effect to a patient in relation to this incident.No sample was available to be returned to the manufacturer for evaluation.Labeling on the hot pack includes a dotted "fold me" line and instructs users "fold to activate." although a definitive root cause for the reported incident could not be determined, user error cannot be ruled out as a cause and/or contributing factor.Due to the need for medical intervention, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the hot pack burst during activation and that a staff member experienced burns.

• Type of Device: PACK,HOT,INSTANT,NON-INSULATED,6"X10"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8320260
• MDR Text Key: 135522229
• Report Number: 1417592-2019-00020
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MDS138005
• Device Lot Number: CN18310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention