MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC HOT PACK; PACK, HOT OR COLD, DISPOSABLE

Catalog Number 11443-012B

Device Problems Leak/Splash (1354); Material Rupture (1546)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

Rn took instant hot pack in to pt and attempted to "squeeze outer edges toward center from arrows".When rn squeezed, the hot pack burst and white wet powder substance went all over room.It got on pt's bed and floor, did not get on pt.Substance did get on rn's fingers and cause her skin to look dry.Rn washed fingers right away.Fda safety report id# (b)(4).

• Brand Name: HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 12975909
• MDR Text Key: 282125764
• Report Number: MW5105956
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11443-012B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR