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

Model Number V11443-012B

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Cardinal health instant hot pack exploded when activating the heat.Internal contents got on employee skin and hands.Fda safety report id # (b)(4).

• Brand Name: INSTANT HOT PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; waukegan IL 60085
• MDR Report Key: 14052781
• MDR Text Key: 289103086
• Report Number: MW5108846
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: V2C018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White