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

Lot Number V9S139

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/05/2020

Event Type  malfunction  

Event Description

Two hands and excessive pressure needed to activate hot pack; it exploded.

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9871594
• MDR Text Key: 184659762
• Report Number: 9871594
• 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: 03/11/2020

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: V9S139
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2020
• Event Location: Other
• Date Report to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1