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

Model Number 11440-900

Device Problems Burst Container or Vessel (1074); Activation Problem (4042)

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

Event Date 03/22/2023

Event Type  malfunction  

Event Description

Our physician assistant was seeing a patient in sports for post op car patient needed cold ice pack to help with the pain after surgery.Medical assistant was getting ready to supply the patient with the icepack and as she was activating the ice pack, it exploded.The entire pack opened, and all the particles flew up in the air.Luckily, no one got hurt and the patient was wearing glasses and as well as the medical assistant.Manufacturer response for pack, hot or cold, disposable, cardinal health (per site reporter).No response as of the filing of this report.Vendor representatives were contacted concerning this event.

• Brand Name: COLD PACKS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 16731698
• MDR Text Key: 313224110
• Report Number: 16731698
• 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: 03/24/2023

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: 11440-900
• Device Catalogue Number: 11440-900
• Device Lot Number: 273916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA
• Patient Sex: Female