MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-012B

Device Problem Burst Container or Vessel (1074)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

Customer reported that the hot pack exploded on the nurse¿s arm while she tried to activate it, causing skin irritation, resolved by washing the area.The nurse is fine now.No further information was provided.

Manufacturer Narrative

Device history review could not be verified as lot number was not provided.No samples were returned for evaluation.Therefore; an evaluation of the complaint device for deficiency of construction could not be performed.We are unable to determine a specific assignable root cause for the reported incident.We will continue to monitor this failure mode for this product.

• Brand Name: HOT PACK, LARGE, 6X9IN
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood dr; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14466115
• MDR Text Key: 300324556
• Report Number: 1423537-2022-00767
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/20/2022

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 Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female