MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; PACK,HOT,INSTANT,MED ,6X6"

Catalog Number	MDS139008
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported via medwatch mw5097300, that during activation, a hot pack exploded in the face of the end-user.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that during activation, a hot pack exploded in the face of the end-user.

• Common Device Name: PACK,HOT,INSTANT,MED ,6X6"
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11071905
• Report Number: 1417592-2020-00158
• Device Sequence Number: 3595709
• Product Code: IMD
• UDI-Device Identifier: 10888277320543
• UDI-Public: 10888277320543
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/24/2020

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MDS139008
• Device Lot Number: CN18339B9
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention