MAUDE Adverse Event Report: MO016 MO-MOBERLY 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 01/31/2022

Event Type  malfunction  

Event Description

It has been reported that a hot pack burst on a nursing care assistant.When the pack burst the contents landed on her hands and eyes causing minor skin irritation and burning to her eyes.She did not seek medical attention but flushed her eyes out and washed her hands.It is reported that she is doing fine.

Manufacturer Narrative

Device history record review was completed on the reported lot v1p242.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 due to which a root cause could not be determined.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): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood rd.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13653720
• MDR Text Key: 291751799
• Report Number: 1423537-2022-00728
• 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: 03/02/2022

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: V1P242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Female