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

Device Problems Break (1069); Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Chemical Exposure (2570)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

Two instant heat packs exploded when cracking open.Nurse needed heat packs opened; both heat packs emitted liquid on nurse and appeared to have holes in them as soon as they were cracked to use.Will monitor occurrence of heat pack malfunctions.

• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9151778
• MDR Text Key: 161075764
• Report Number: 9151778
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• 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: 09/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1