MAUDE Adverse Event Report: HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number O0823GST

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

Iv team in to place iv.Hot pack activated, broke and splashed onto patient skin; immediately wiped away, no injury noted.Hot pack saved and will notify supply chain; lot#o0823gst (b)(4) medical.Fda safety report id# (b)(4).

• Brand Name: HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• MDR Report Key: 13315457
• MDR Text Key: 284355715
• Report Number: MW5106877
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2022

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 Lot Number: O0823GST
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2022
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female