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

Lot Number O0823GST

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

Rn attempted to activate a 'squeeze to activate' heating pack.When rn squeezed the heating pack with one hand, it popped, exploding the crystallizing gel and beads onto herself.Hands were immediately washed with soap and water.Charge nurse notified of defective equipment.(b)(6).Fda safety report id# (b)(4).

• Brand Name: HOTPACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• MDR Report Key: 13059948
• MDR Text Key: 282776077
• Report Number: MW5106206
• 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: 12/16/2021

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 Lot Number: O0823GST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White