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

Device Problems Melted (1385); Material Puncture/Hole (1504); Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2020

Event Type  malfunction  

Event Description

Rn went to open the hot pack, a large hole opened on the pack when it was bent in half and the melted wax landed on the chest and right hand of rn.

• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9990350
• MDR Text Key: 188659376
• Report Number: 9990350
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1