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

Lot Number V7A258

Device Problems Burst Container or Vessel (1074); Material Split, Cut or Torn (4008)

Patient Problem Chemical Exposure (2570)

Event Date 07/26/2018

Event Type  malfunction  

Event Description

Patient approached this rn and stated that instant hot pack exploded on her stomach.Upon assessment, this rn noted patient to have contents of hot pack over her arms and stomach.Rn instructed patient to wash effected body parts with soap and water per the packages instructions.Rn noted hot pack to have a small tear in the bottom of the package.Rn asked if patient had been lying on the heat pack, patient stated that hot pack was being used on top of her stomach without applying pressure.

• Brand Name: CARDINAL HEALTH 200 LLC.
• 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: 7826110
• MDR Text Key: 118572017
• Report Number: 7826110
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2018

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: Lay User/Patient
• Device Lot Number: V7A258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1