MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC UNKNOWN PRODUCT-MED; PACK, HOT OR COLD, DISPOSABLE

Model Number UNKNOWN PRODUCT-MED

Device Problem Burst Container or Vessel (1074)

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

Event Date 06/04/2022

Event Type  malfunction  

Event Description

Mw5110250 reported that the hot pack burst with its contents running down patient's privates and leg.There was no injury.Customer was unable to provide a product number, lot number, demographics or other supporting data.

Manufacturer Narrative

Based on the investigation, the device history record could not be reviewed as the lot number was not provided.A sample was not available for investigation.The root cause for the reported concern cannot be identified with the information provided.Without a specific assignable cause, no specific corrective actions can be completed; however, we will continue to monitor this failure mode for this product.

• Brand Name: UNKNOWN PRODUCT-MED
• 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: 15048124
• MDR Text Key: 304472403
• Report Number: 1423537-2022-00803
• 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: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN PRODUCT-MED
• Device Catalogue Number: UNKNOWN PRODUCT-MED
• Device Lot Number: UNKOWN
• Date Manufacturer Received: 06/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1