MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC HOT PACK, SMALL, 4.5X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-512B

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/09/2022

Event Type  malfunction  

Manufacturer Narrative

Dhr reviews were completed on the reported lot: v2d034.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.No samples were returned for investigation due to which a root cause could not be determined.Cardinal will continue to monitor complaint trends for this product.

Event Description

Customer reported when activating the warm pack, its content burst out of the packaging landing on patient¿s hair (top of head), eyebrows and chest; patient stated she also tasted the content of the warm pack.Contents washed off by patient and clinician.Skin remained intact and no skin/eye irritation reported.

• Brand Name: HOT PACK, SMALL, 4.5X9IN
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15396536
• MDR Text Key: 305808087
• Report Number: 1423537-2022-00836
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380168406
• UDI-Public: 10885380168406
• 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: Other
• Type of Report: Initial
• Report Date: 09/09/2022

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: 11443-512B
• Device Catalogue Number: 11443-512B
• Device Lot Number: V2D034
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/09/2022
• Date Device Manufactured: 04/04/2022
• 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