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

Lot Number V7C280

Device Problems Burst Container or Vessel (1074); Device Emits Odor (1425)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

Event Description

The female patient was using self heating heat packs.One pack exploded on patient and on her bed clothing.The patient was not injured but, there was a brownish stain and burnt smell to the bed clothing and sheets.Spd was contacted and cardinal health was notified.

• Brand Name: CARDINAL HEALTH INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.; 808 w highway 24; moberly MO 65270
• MDR Report Key: 6893991
• MDR Text Key: 87451398
• Report Number: 6893991
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2017,09/19/2017

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: No Information
• Device Lot Number: V7C280
• Other Device ID Number: 10630140013751
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 33 YR