MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INSTANT HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Model Number MDS139008

Device Problem Break (1069)

Patient Problem Chemical Exposure (2570)

Event Date 12/13/2020

Event Type  Injury  

Event Description

I was attempting to squeeze out packaging to activate instant hot pack and it exploded all over me.Fda safety report id# (b)(4).

• Brand Name: MEDLINE INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 11348028
• MDR Text Key: 232901127
• Report Number: MW5099485
• Device Sequence Number: 1
• Product Code: IMD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/16/2021

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: Health Professional
• Device Model Number: MDS139008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention